JHX · Class II · 21 CFR 862.1215

FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes

Leading manufacturers include Beckman Coulter, Inc., Diagnostic Products Corp. and Corning Medical & Scientific.

48
Total
48
Cleared
73d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Fluorometric Method, Cpk Or Isoenzymes Devices (Product Code JHX)

48 devices
1–24 of 48
Cleared Feb 16, 2024
Access CK-MB
K234005
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
K212648
Ortho-Clinical Diagnostics
Chemistry · 158d
Cleared Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
K051650
Dade Behring, Inc.
Chemistry · 79d
Cleared Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
K034055
Diagnostic Products Corp.
Chemistry · 22d
Cleared Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
K030012
Beckman Coulter, Inc.
Chemistry · 15d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118
Diagnostic Products Corp.
Chemistry · 21d
Cleared Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
K004002
Diagnostic Products Corp.
Chemistry · 50d
Cleared Mar 20, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
K000716
Beckman Coulter, Inc.
Chemistry · 17d
Cleared Jan 14, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
K994439
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Oct 04, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068
Ortho-Clinical Diagnostics
Chemistry · 21d
Cleared Jun 09, 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067
Dade Behring, Inc.
Chemistry · 58d
Cleared May 26, 1998
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099
Dade Behring, Inc.
Chemistry · 61d
Cleared Oct 06, 1997
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
K973126
Biosite Incorporated
Chemistry · 47d
Cleared Aug 30, 1996
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549
Biomerieux Vitek, Inc.
Chemistry · 63d
Cleared Apr 03, 1991
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121
Ciba Corning Diagnostics Corp.
Chemistry · 22d
Cleared May 16, 1988
BIOTROL CK MONOEACTIF
K881267
Biotrol, USA, Inc.
Chemistry · 53d
Cleared Nov 23, 1987
TITAN GEL REP CPK-6 HV
K874144
Helena Laboratories
Chemistry · 41d
Cleared Oct 20, 1987
TITAN GEL CPK REP SYSTEM
K873399
Helena Laboratories
Chemistry · 57d
Cleared Sep 29, 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171
American Dade
Chemistry · 49d
Cleared May 26, 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
K870987
Ciba Corning Diagnostics Corp.
Chemistry · 76d
Cleared May 07, 1984
CK-B RIA KIT
K840549
Diagnostic Systems Laboratories, Inc.
Chemistry · 89d
Cleared Jan 18, 1982
CARDIOTRAC CORNING CK ISOENZYME SUBST
K813573
Corning Medical & Scientific
Chemistry · 27d
Cleared Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826
Beckman Instruments, Inc.
Chemistry · 60d

About Product Code JHX - Regulatory Context

510(k) Submission Activity

48 total 510(k) submissions under product code JHX since 1976, with 48 receiving FDA clearance (average review time: 73 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.