Product code JHY— Clinical Chemistry
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
- Classification name
- Colorimetric Method, Cpk Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 40
- First cleared
- Most recent
Market context for product code JHY
FDA has cleared devices under product code JHY between 1976 and 2015, filed by 32 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- 2015
- 2014
- 2013
- 2007
- 2002
- 1997
- 1996
- 1995
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
Top applicants under product code JHY
Recent clearances under product code JHY
- K143720 — Dimension Vista MMB Assay
- K130080 — EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
- K140404 — ELECSYS CK-MB STAT IMMUNOASSAY
- K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
- K070835 — OLYMPUS CK-MB REAGENT
- K022757 — SPIFE CK KIT, MODEL 3332, 3333
- K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
- K974421 — ELECSYS CK-MB STAT
- K970343 — MMB METHOD
- K961412 — CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
- K951638 — AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK
- K931172 — IMX(R) STAT CK-MB
- K924429 — OPUS(R) CK-MB
- K922700 — DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
- K921763 — TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
- K912766 — AMERLITE CK-MB ASSAY
- K896240 — COBAS READY CK REAGENT
- K895870 — ISOSCREEN-CK CONFIRMATORY KIT
- K890295 — TARGET(TM) CK-MB
- K884550 — CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
- K884085 — TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
- K883013 — IMX CKMB
- K881351 — IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
- K875192 — KODAK EKTACHEM DT SLIDES (CKMB)
- K880178 — CREATINE KINASE (COLORIMETRIC METHOD)
- K874545 — IMACK-MB TEST PROCEDURE (MODIFICATION)
- K872063 — TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
- K871677 — CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS
- K860663 — AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT
- K845024 — BAKER CKMB REAGENT SET
- K832977 — FLOW-PAC CPK REAGENT SET
- K832139 — TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY
- K832004 — WAKO CPK TEST
- K830672 — CREATINE KINASE REAGENT SET
- K820812 — CREATINE KINASE-MB KIT
- K800684 — REAGENT FOR DETERM. CREATINE PHOSPHOKINA
- K791655 — CPK ISOENZYME REAGENT
- K790309 — CPK ISOENZYME SUBSTRATE
- K761212 — CPK1SOENZYMES DETERMINATION PRO. #715-EP
- K760871 — LANCER MB/CPK ISOENZYME KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.