Chromatographic Separation, Cpk Isoenzymes
FDA product code JHT · 21 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1215
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-09-15 – 2002-09-30
JHT
2002-09-30
JHT
1999-05-28
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
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JHT
1993-04-12
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
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JHT
1990-12-13
COULTER CK-MB ISOENZYME REAGENT
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JHT
1990-12-13
DSL CK-MB (DSL #3200)
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JHT
1990-05-15
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
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JHT
1990-02-16
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
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JHT
1988-11-10
CREATINE KINASE (CK) ISOENZYME MB
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JHT
1988-01-21
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
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JHT
1987-09-16
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
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JHT
1987-08-03
MICROMI-CK(TM)
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JHT
1987-07-31
IMACK-MB(TM)
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JHT
1983-11-04
SHOT GUN KIT FOR CK-MB
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JHT
1983-01-07
CK-ISOZYME U.V. REAGENT SET
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JHT
1982-11-01
TITAN GEL CPK ISOENZYME SYSTEM
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JHT
1982-07-22
125I QUICK-MB TEST KIT FOR QUANTITATION
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JHT
1981-03-11
GEMENI QUICK-MB SEPARATION KIT
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JHT
1979-10-01
CPK CLINI GEL KIT
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JHT
1979-04-04
CPK-CS
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JHT
1977-08-22
CK-MB
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JHT
1976-09-15
CPK - ISOENZYMES
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