Product code JHT— Clinical Chemistry
125I QUICK-MB TEST KIT FOR QUANTITATION
- Classification name
- Chromatographic Separation, Cpk Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 21
- First cleared
- Most recent
Market context for product code JHT
FDA has cleared devices under product code JHT between 1976 and 2002, filed by 15 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
- 2002
- 1999
- 1993
- 1990
- 1988
- 1987
- 1983
- 1982
- 1981
- 1979
- 1977
- 1976
Top applicants under product code JHT
Recent clearances under product code JHT
- K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
- K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
- K930359 — CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
- K904721 — DSL CK-MB (DSL #3200)
- K904866 — COULTER CK-MB ISOENZYME REAGENT
- K901450 — MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
- K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
- K881168 — CREATINE KINASE (CK) ISOENZYME MB
- K874284 — SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
- K872041 — COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
- K872598 — MICROMI-CK(TM)
- K872592 — IMACK-MB(TM)
- K831391 — SHOT GUN KIT FOR CK-MB
- K823550 — CK-ISOZYME U.V. REAGENT SET
- K822124 — TITAN GEL CPK ISOENZYME SYSTEM
- K821964 — 125I QUICK-MB TEST KIT FOR QUANTITATION
- K810534 — GEMENI QUICK-MB SEPARATION KIT
- K791826 — CPK CLINI GEL KIT
- K790357 — CPK-CS
- K771497 — CK-MB
- K760028 — CPK - ISOENZYMES
Data sourced from openFDA. This site is unofficial and independent of the FDA.