Product code JHS— Clinical Chemistry
ACA CREATINE KINASE ISOENZYMES
- Classification name
- Differential Rate Kinetic Method, Cpk Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 38
- First cleared
- Most recent
Market context for product code JHS
FDA has cleared devices under product code JHS between 1978 and 2016, filed by 29 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2011
- 2008
- 2006
- 1999
- 1998
- 1996
- 1995
- 1994
- 1990
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code JHS
Recent clearances under product code JHS
- K160570 — Creatine Kinase
- K102706 — CKMB UDR ASSAY
- K082226 — S40 CREATINE KINASE (CK)
- K062128 — THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
- K990434 — CARESIDE CKMB
- K990439 — CARESIDE CK
- K981495 — IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
- K962126 — ACS CKMB II IMMUNOASSAY
- K952250 — STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT
- K945083 — ACCESS CK-MB REAGENTS
- K943024 — KINASE ISOENZYME
- K941584 — CREATINE KINASE METHOD
- K903025 — ROCHE ISOMUNE- CK
- K900806 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- K883223 — CHECK-MM
- K872029 — UNI-FAST CREATINE KINASE TEST (CK)
- K861387 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
- K855188 — CPK (UV) REAGENT KIT
- K854708 — DART CK-MB REAGENT SYSTEM
- K843007 — CARDI-CK EIA TEST KIT CK-MB ISOENZYME
- K823211 — CK-UV REAGENT
- K820722 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
- K813406 — CPK(CK) IN VITRO DIAG. REAGENT SET
- K810997 — WORTHINGTON CK (NAC) REAGENT SET
- K803169 — CARDIOZYME PLUS CK-TOTAL #65046
- K802521 — CK-MB(IMMUNOLOGICAL)
- K801668 — QUICK CEPT
- K800028 — WORTHINGTON FLOZYME* CPK (340NM)
- K792023 — ESKACHEM, CK-MB REAGENT
- K790916 — CK-NUC REAGENT
- K790917 — SPIN CHEM CK-NAC REAGENT
- K790918 — ESKLAB REAGENT TABLETS
- K790343 — DATA-ZYME CK CALORIMETRIC/UV PROCEDURE
- K790088 — ACA CREATINE KINASE ISOENZYMES
- K790015 — SERUM, CREATININE PHOSPHOKINASE
- K781690 — L-CYSTEINE HYDROCHLORIDE
- K781432 — STAT ULTRA VIOLET LIQUID
- K780504 — CREATINE PHOSPHOKINASE (CPK)
Data sourced from openFDA. This site is unofficial and independent of the FDA.