FDA Product Code JHX: Fluorometric Method, Cpk Or Isoenzymes
Leading manufacturers include Beckman Coulter, Inc., Diagnostic Products Corp. and Dade Behring, Inc..
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
Cleared
Feb 16, 2024
Access CK-MB
Beckman Coulter, Inc.
Chemistry
59d
Cleared
Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho-Clinical Diagnostics
Chemistry
158d
Cleared
Sep 08, 2005
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK
Dade Behring, Inc.
Chemistry
79d
Cleared
Jan 21, 2004
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
Diagnostic Products Corp.
Chemistry
22d
Cleared
Jan 17, 2003
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
Beckman Coulter, Inc.
Chemistry
15d
Cleared
Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
Diagnostic Products Corp.
Chemistry
21d
Cleared
Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
Diagnostic Products Corp.
Chemistry
50d
Cleared
Mar 20, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
Beckman Coulter, Inc.
Chemistry
17d
Cleared
Jan 14, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
Beckman Coulter, Inc.
Chemistry
22d
Cleared
Jun 09, 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
Diagnostic Products Corp.
Chemistry
14d
Cleared
Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
Dade Behring, Inc.
Chemistry
58d
Cleared
May 26, 1998
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
Dade Behring, Inc.
Chemistry
61d
Cleared
Nov 23, 1987
TITAN GEL REP CPK-6 HV
Helena Laboratories
Chemistry
41d
Cleared
Oct 20, 1987
TITAN GEL CPK REP SYSTEM
Helena Laboratories
Chemistry
57d
Cleared
Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
Beckman Instruments, Inc.
Chemistry
60d
Cleared
Jul 14, 1980
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
Helena Laboratories
Chemistry
36d
Cleared
Oct 29, 1976
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
Sigma Chemical Co.
Chemistry
52d
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.