Albumin, Antigen, Antiserum, Control

FDA product code DCF · 35 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5040
Review panel: IM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-04-07 – 2016-08-25

DCF 2016-08-25

Optilite Low Level Albumin Kit

Applicant The Binding Site Group , Ltd.

K number K153560

View details →

DCF 2013-06-19

HUMAN ALBUMIN CSF KIT

Applicant The Binding Site Group , Ltd.

K number K121045

View details →

DCF 2012-05-14

TINA-QUANT ALBUMIN GEN.2

Applicant Roche Diagnostics Operations

K number K113072

View details →

DCF 2011-07-13

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

Applicant Medica Corp.

K number K101089

View details →

DCF 2010-09-10

TINA-QUANT ALBUMIN GEN 2

Applicant Roche Diagnostics

K number K101203

View details →

DCF 2010-09-09

COBAS 8000 MODULAR SERIES ANALYZER

Applicant Roche Diagnostics Corp.

K number K100853

View details →

DCF 2010-04-29

K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR

Applicant Kamiya Biomedical Co.

K number K091486

View details →

DCF 2009-04-08

SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100

Applicant Beckman Coulter, Inc.

K number K082251

View details →

DCF 2006-09-19

DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL

Applicant Dade Behring, Inc.

K number K061990

View details →

DCF 2006-03-09

NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL

Applicant Polymedco, Inc.

K number K053553

View details →

DCF 2005-07-05

DCL MICROALBUMIN ASSAY, MODEL 252-20

Applicant Diagnostic Chemicals , Ltd.

K number K051191

View details →

DCF 2004-11-18

VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042643

View details →

DCF 2004-01-12

DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114

Applicant Dade Behring, Inc.

K number K033525

View details →

DCF 1997-10-20

N ANTISERUM TO HUMAN ALBUMIN

Applicant Behring Diagnostics, Inc.

K number K972929

View details →

DCF 1997-04-29

IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT

Applicant Beckman Instruments, Inc.

K number K964695

View details →

DCF 1996-07-23

COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN

Applicant Roche Diagnostic Systems, Inc.

K number K961824

View details →

DCF 1995-09-15

LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM

Applicant International Enzymes, Inc.

K number K953927

View details →

DCF 1991-12-10

ALBUMIN TEST RID KIT

Applicant The Binding Site, Ltd.

K number K914391

View details →

DCF 1990-01-22

TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT

Applicant Behring Diagnostics, Inc.

K number K900167

View details →

DCF 1989-11-06

MODIFIED QM300 ALBUMIN ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K896059

View details →

DCF 1989-10-17

TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN

Applicant Technicon Instruments Corp.

K number K895808

View details →

DCF 1988-08-04

TECHNICON DPA-1(TM) SYSTEM

Applicant Technicon Instruments Corp.

K number K882153

View details →

DCF 1988-07-08

QM300 ALBUMIN ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K882082

View details →

DCF 1988-04-21

QM300 CALIBRATOR D PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K881127

View details →

DCF 1988-04-06

QM300 ALBUMIN ANTIBODY PACK

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K881126

View details →

DCF 1988-02-17

MAT (TM) MICROALBUMIN TEST

Applicant Wampole Laboratories

K number K875161

View details →

DCF 1987-10-20

ALBUMIN IN SERUM

Applicant Unipath , Ltd.

K number K873862

View details →

DCF 1987-10-13

ALBUMIN IN URINE

Applicant Unipath , Ltd.

K number K873861

View details →

DCF 1986-09-18

MICROALBUMINURIA ASSAY

Applicant Orion Corp.

K number K862671

View details →

DCF 1985-06-17

RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI

Applicant Cooper Biomedical, Inc.

K number K851285

View details →

DCF 1981-09-23

IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM

Applicant Dako Corp.

K number K812496

View details →

DCF 1980-10-23

ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE

Applicant Ortho Diagnostics, Inc.

K number K802404

View details →

DCF 1978-06-22

ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM

Applicant Beckman Instruments, Inc.

K number K780913

View details →

DCF 1977-10-07

QUAN. COLOR. DETER. OF SERUM ALBUMIN

Applicant Stanbio Laboratory

K number K771771

View details →

DCF 1977-04-07

LOW LEVEL HUMAN ALBUMIN TEST KITS

Applicant Intl. Diagnostic Technology

K number K761225

View details →