Product code JHW— Clinical Chemistry
A-GENT CK-MB
- Classification name
- U.V. Method, Cpk Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 27
- First cleared
- Most recent
Market context for product code JHW
FDA has cleared devices under product code JHW between 1977 and 2017, filed by 18 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- 2017
- 2014
- 2012
- 2003
- 2000
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
- 1988
- 1982
- 1981
- 1980
Top applicants under product code JHW
Recent clearances under product code JHW
- K162526 — Creatine Kinase-MB
- K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
- K122083 — ELITECH CLINICAL SYSTEMS CK NAC SL
- K023744 — WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
- K003158 — ROCHE DIAGNOSTICS CK-MB
- K961501 — ELECSYS CK-MB
- K950186 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
- K944325 — LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
- K942958 — CREATINE KINASE MB DETERMINATION (UV)
- K935924 — AXSYM CK-MB
- K931050 — CARDIO REP CK ISOENZYME KIT - 3310
- K913349 — STAMBI-CK
- K912231 — PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
- K905588 — CREATINE KINASE UV REAGENT SET
- K903508 — LABELLING CHANGES TO IMPRES-MB-X
- K883222 — ISOFOR-MM (TM)
- K881801 — IMPRES-MB
- K822897 — DSL 1700
- K811573 — CARDIOZYME PLUS CK-MB ITEM #65045
- K811575 — CARDIOZYME PLUS CK-MB ITEM #65045 (G)
- K810861 — CREATINE KINASE MB ISOENZYME IMMUNO UV
- K810905 — ISOMUNE-CK
- K803168 — CARDIO ZYME PLUS CK-MB #65045
- K792533 — CREATINE PHOSPHOKINASE (CPK) REAGENT SET
- K782015 — A-GENT CK-MB
- K781124 — CPK ISOENZYME REAGENT
- K772172 — DYNAZYME TM II CARDIAK-MB
Data sourced from openFDA. This site is unofficial and independent of the FDA.