Fluorometric Method, Cpk Or Isoenzymes

JHX 2022-01-28

VITROS Immunodiagnostic Products CK-MB Reagent Pack

Applicant Ortho Clinical Diagnostics

K number K212648

JHX 2017-09-21

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

Applicant Radiometer Medical Aps

K number K163462

JHX 2012-11-21

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

Applicant Radiometer Medical Aps

K number K120326

JHX 2009-08-17

PATHFAST CK-MB-II, PATHFAST MYO-II

Applicant Mitsubishi Kagaku Iatron

K number K081360

JHX 2005-09-08

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

Applicant Dade Behring, Inc.

K number K051650

JHX 2004-07-21

ARCHITECT STAT CK-MB IMMUNOASSAY

Applicant Fisher Diagnostics

K number K041596

JHX 2004-05-17

RAMP CK-MB ASSAY

Applicant Response Biomedical Corp.

K number K033747

JHX 2004-01-21

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

K number K034055

JHX 2003-01-17

CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372

Applicant Beckman Coulter, Inc.

K number K030012

JHX 2002-07-22

IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

K number K022118

JHX 2001-10-15

MODIFICATION TO ALPHA DX SYSTEM

Applicant First Medical, Inc.

K number K013118

JHX 2001-02-14

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

K number K004002

JHX 2000-03-20

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER

Applicant Beckman Coulter, Inc.

K number K000716

JHX 2000-01-14

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306

Applicant Beckman Coulter, Inc.

K number K994439

JHX 1999-10-04

VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS

Applicant Ortho-Clinical Diagnostics

K number K993068

JHX 1999-06-09

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

K number K991797

JHX 1999-01-13

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK

Applicant Dade Behring, Inc.

K number K984067

JHX 1998-05-26

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK

Applicant Dade Behring, Inc.

K number K981099

JHX 1998-02-25

CREATINE KINASE REAGENT

Applicant Ac Biochemicals, Inc.

K number K980012

JHX 1997-10-06

TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I

Applicant Biosite Incorporated

K number K973126

JHX 1997-08-15

DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Dade Intl., Inc.

K number K972782

JHX 1996-08-30

VIDAS CREATINE KINASE MB ASSAY 30-421

Applicant Biomerieux Vitek, Inc.

K number K962549

JHX 1992-04-22

MYDAS(TM)-MB2/MYDAS(TM)-MB

K number K913380

JHX 1991-09-27

AIA-PACK CK-MB

Applicant Tosoh Corp.

K number K913298

JHX 1991-04-03

CIBA CORNING ACS CKMB IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K911121

JHX 1990-11-06

MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS

K number K903441

JHX 1989-03-13

IMPRES-MB REAGENT A AND REAGENT B

K number K890543

JHX 1988-05-16

BIOTROL CK MONOEACTIF

Applicant Biotrol, USA, Inc.

K number K881267

JHX 1988-04-28

CREATINE KINASE (CK) REAGENT SET

Applicant Tech-Neal Scientific, Inc.

K number K881237

JHX 1987-11-23

TITAN GEL REP CPK-6 HV

Applicant Helena Laboratories

K number K874144

JHX 1987-10-20

TITAN GEL CPK REP SYSTEM

Applicant Helena Laboratories

K number K873399

JHX 1987-09-29

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant American Dade

K number K873171

JHX 1987-05-26

CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K870987

JHX 1984-05-07

CK-B RIA KIT

Applicant Diagnostic Systems Laboratories, Inc.

K number K840549

JHX 1982-01-18

CARDIOTRAC CORNING CK ISOENZYME SUBST

K number K813573

JHX 1981-12-17

ABURIA-CK RIA TEST KIT

K number K813087

JHX 1981-10-19

NML CK-MB RIA

Applicant Nuclear Medical Laboratories, Inc.

K number K812759

JHX 1981-01-09

PARAGON ELECTRO. CREATINE KINASE TEST KI

Applicant Beckman Instruments, Inc.

K number K802826

JHX 1980-09-26

EMBRIA-CK

K number K801728

JHX 1980-07-14

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE

Applicant Helena Laboratories

K number K801318

JHX 1980-03-20

CORNING TRANSPHOR

K number K800544

JHX 1980-01-16

RIA-QUANT CK-MB TEST KIT

Applicant Mallinckrodt Critical Care

K number K792504

JHX 1979-11-15

CARDIO CK-B RIA KIT

Applicant Nuclear Medical Systems, Inc.

K number K791582

JHX 1979-03-21

BUFFER, CORNING MOPSO

K number K790294

JHX 1977-09-15

CREATINE KINASE ISOENZYME SUBSTRATE SET

Applicant Pfizer Pharmaceuticals

K number K771605

JHX 1977-09-02

3-(N-MORPHOLINS)-PROPANE SULFONIC ACID

K number K771324

JHX 1976-10-29

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

Applicant Sigma Chemical Co.

K number K760591