System, Multipurpose For In Vitro Coagulation Studies

FDA product code JPA · 179 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.5425
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-24 – 2026-04-27

JPA 1993-02-12

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376

Applicant Helena Laboratories

K number K926222

View details →

JPA 1993-01-21

ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM

Applicant International Technidyne Corp.

K number K923761

View details →

JPA 1992-12-21

CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION

Applicant Behring Diagnostics, Inc.

K number K924509

View details →

JPA 1992-12-18

MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)

Applicant Organon Teknika Corp.

K number K924453

View details →

JPA 1992-12-01

BEHRING FIBRINTIMER A

Applicant Behring Diagnostics, Inc.

K number K924124

View details →

JPA 1992-11-16

STANDARD HUMAN PLASMA

Applicant Behring Diagnostics, Inc.

K number K924393

View details →

JPA 1992-08-26

KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K914188

View details →

JPA 1991-09-19

ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS

Applicant Instrumentation Laboratory CO

K number K912087

View details →

JPA 1991-07-24

HEPARIN ADSORBENT

Applicant Sigma Diagnostics, Inc.

K number K912061

View details →

JPA 1990-08-01

ACS 0.02 M CALCIUM CHLORIDE

Applicant Analytical Control Systems, Inc.

K number K902458

View details →

JPA 1990-04-16

COAG-A-MATE - RA4

Applicant Organon Teknika Corp.

K number K900917

View details →

JPA 1990-03-12

MODIFIED COATRON II AND COATRON JR.

Applicant Astral Medical Systems

K number K900506

View details →

JPA 1990-03-06

COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN

Applicant Baxter Healthcare Corp

K number K900377

View details →

JPA 1989-09-05

HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS

Applicant Hemotec, Inc.

K number K894466

View details →

JPA 1989-09-05

CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS

Applicant Hemotec, Inc.

K number K894359

View details →

JPA 1989-06-23

PLATELET AGGREGATION PROFILER MODEL PAP-4C

Applicant Bio/Data Corp.

K number K893650

View details →

JPA 1989-01-24

PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER

Applicant Pall Biomedical Products Co.

K number K884534

View details →

JPA 1988-12-30

COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE

Applicant Organon Teknika Corp.

K number K885076

View details →

JPA 1988-11-01

ORTHO OWREN'S BUFFER

Applicant Ortho Diagnostic Systems, Inc.

K number K883689

View details →

JPA 1988-10-31

KD ONE-STAGE PROTHROMBIN TIME TEST

Applicant King Diagnostics, Inc.

K number K883640

View details →

JPA 1988-10-31

KD 0.02 M CALCIUM CHLORIDE SOLUTION

Applicant King Diagnostics, Inc.

K number K883637

View details →

JPA 1988-10-31

KD 0.1 M SODIUM CITRATE SOLUTION

Applicant King Diagnostics, Inc.

K number K883635

View details →

JPA 1988-08-25

OWREN'S VERONAL BUFFER

Applicant Helena Laboratories

K number K883484

View details →

JPA 1988-08-25

COAG-I ANALYZER, ALPHA MODEL

Applicant Cardiovascular Diagnostic Services

K number K882444

View details →

JPA 1988-06-27

ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS

Applicant Instrumentation Laboratory CO

K number K881367

View details →

JPA 1988-03-18

CLP 0.1 M SODIUM CITRATE SOLUTION

Applicant Creative Laboratory Products, Inc.

K number K880713

View details →

JPA 1988-03-09

HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN

Applicant Hemotec, Inc.

K number K875089

View details →

JPA 1987-07-09

CHROM-TROL

Applicant Helena Laboratories

K number K872377

View details →

JPA 1987-06-01

PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA

Applicant International Technidyne Corp.

K number K870831

View details →

JPA 1987-04-23

PT HEPARIN ADSORBENT

Applicant Probe-Tek, Inc.

K number K870771

View details →

JPA 1987-04-20

COAGULATION CONTROL, LEVEL III

Applicant U. S. Diagnostics, Inc.

K number K870687

View details →

JPA 1987-04-20

COAGULATION CONTROL, LEVEL II

Applicant U. S. Diagnostics, Inc.

K number K870686

View details →

JPA 1987-04-20

COAGULATION CONTROL, LEVEL I

Applicant U. S. Diagnostics, Inc.

K number K870685

View details →

JPA 1987-03-31

O.O2 M CALCIUM CHLORIDE SOLUTION

Applicant U. S. Diagnostics, Inc.

K number K870688

View details →

JPA 1987-03-17

COAG-A-MATE(R) XC

Applicant Organon Teknika Corp.

K number K870960

View details →

JPA 1987-02-06

ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER

Applicant Medical Laboratory Automation Systems, Inc.

K number K864534

View details →

JPA 1987-02-06

ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER

Applicant Medical Laboratory Automation Systems, Inc.

K number K864532

View details →

JPA 1986-11-25

IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA

Applicant Instrumentation Laboratory CO

K number K864271

View details →

JPA 1986-07-21

KOAGULAB* M COAGULATION SYSTEM

Applicant Ortho Diagnostic Systems, Inc.

K number K862537

View details →

JPA 1986-05-23

BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)

Applicant Biotrack, Inc.

K number K860719

View details →

JPA 1986-03-12

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.

Applicant Diatech, Inc.

K number K854938

View details →

JPA 1986-03-04

MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP

Applicant Bio/Data Corp.

K number K860342

View details →

JPA 1986-01-07

MICROSAMPLE COAGULATION ANALYSER MODEL 110P

Applicant Bio/Data Corp.

K number K854546

View details →

JPA 1986-01-06

DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT

Applicant Diatech, Inc.

K number K854090

View details →

JPA 1986-01-06

DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT

Applicant Diatech, Inc.

K number K854089

View details →

JPA 1985-12-04

HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS

Applicant Hemotec, Inc.

K number K854376

View details →

JPA 1985-11-12

THROMBOPLASTIN-R REAGENT

Applicant American Dade

K number K853986

View details →

JPA 1985-11-05

KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS

Applicant Ortho Diagnostic Systems, Inc.

K number K853328

View details →

JPA 1985-11-05

COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE

Applicant Astral Medical Systems

K number K851153

View details →

JPA 1985-10-04

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR

Applicant Hemotec, Inc.

K number K853789

View details →

JPA 1985-10-04

ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES

Applicant Medical Device Consultants, Inc.

K number K853198

View details →

JPA 1985-09-30

LODE COAGULOMETER MODEL LC-6

Applicant Lode Corp.

K number K852450

View details →

JPA 1985-08-13

CALCIUM CHLORIDE

Applicant Bio/Data Corp.

K number K853246

View details →

JPA 1985-08-12

CITREX III

Applicant Bio/Data Corp.

K number K853078

View details →

JPA 1985-08-12

CITREX II

Applicant Bio/Data Corp.

K number K853077

View details →

JPA 1985-08-12

CITREX I

Applicant Bio/Data Corp.

K number K853076

View details →

JPA 1985-05-29

DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K851127

View details →

JPA 1985-05-08

GEN. DIAG. CHROMOSTRATE REF. PLASMA

Applicant Warner-Lambert Co.

K number K850409

View details →

JPA 1984-10-17

COBAS-FIBRO

Applicant Roche Diagnostic Systems, Inc.

K number K842717

View details →

JPA 1984-06-01

OWREN'S VERONAL BUFFERR

Applicant Diatech, Inc.

K number K841523

View details →

JPA 1984-06-01

HEPARIN COAGULATION CONTROL PLASMA 1-

Applicant Diatech, Inc.

K number K841462

View details →

JPA 1983-11-03

THROMBOPLASTIN - FS

Applicant American Dade

K number K833272

View details →

JPA 1983-08-12

ORTHO ABNORMAL COAGULATION LEVEL I/II

Applicant Ortho Diagnostic Systems, Inc.

K number K832225

View details →

JPA 1981-11-16

DIGICLOT 2-#820

Applicant Volu Sol Medical Industries

K number K812121

View details →

JPA 1981-11-10

MULTI CLOT-#819

Applicant Volu Sol Medical Industries

K number K812122

View details →

JPA 1981-10-02

MLA ELECTRA 700

Applicant Medical Laboratory Automation Systems, Inc.

K number K812124

View details →

JPA 1979-12-04

NORM-TROL

Applicant Helena Laboratories

K number K792310

View details →

JPA 1979-09-17

ELVI 818 DIGICLOT MULTISCAN

Applicant Volu Sol Medical Industries

K number K791586

View details →

JPA 1979-03-21

COAG-A-MATE 2001

Applicant General Diagnostics

K number K790323

View details →

JPA 1979-03-12

PLASMA, STANDARDIZED NORMAL

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K790204

View details →

JPA 1978-06-14

MLA ELECTRA 750 COAGULATION TIMER

Applicant Medical Laboratory Automation Systems, Inc.

K number K780810

View details →

JPA 1977-05-06

ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH

Applicant Damon Corp.

K number K770606

View details →

JPA 1977-02-01

TPC-LYOPHILIZED POOLED HUMAN PLASMA

Applicant Bio/Data Corp.

K number K761091

View details →

JPA 1977-01-10

CALCIUM CHLORIDE (0.025M)

Applicant Bio/Data Corp.

K number K761176

View details →

JPA 1977-01-10

IMIDAZOLE BUFFER (0.05M)

Applicant Bio/Data Corp.

K number K761175

View details →

JPA 1977-01-10

TRIS BUFFERED

Applicant Bio/Data Corp.

K number K761173

View details →

JPA 1977-01-10

TRIS BUFFERED SALINE

Applicant Bio/Data Corp.

K number K761172

View details →

JPA 1977-01-10

VERONAL BUFFER

Applicant Bio/Data Corp.

K number K761171

View details →

JPA 1976-11-24

AUTO-FI COAGULATION INSTRUMENT

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K760594

View details →