U.V. Method, Cpk Isoenzymes
FDA product code JHW · 26 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
- 1977-12-06 – 2017-05-26
JHW
2017-05-26
JHW
2012-08-22
ELITECH CLINICAL SYSTEMS CK NAC SL
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JHW
2003-01-03
WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
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JHW
2000-12-18
ROCHE DIAGNOSTICS CK-MB
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JHW
1996-06-11
ELECSYS CK-MB
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JHW
1995-03-13
CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
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JHW
1995-02-22
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
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JHW
1994-11-21
CREATINE KINASE MB DETERMINATION (UV)
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JHW
1994-06-21
AXSYM CK-MB
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JHW
1993-04-20
CARDIO REP CK ISOENZYME KIT - 3310
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JHW
1991-10-23
STAMBI-CK
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JHW
1991-07-08
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
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JHW
1991-01-17
CREATINE KINASE UV REAGENT SET
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JHW
1990-09-07
LABELLING CHANGES TO IMPRES-MB-X
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JHW
1988-09-30
ISOFOR-MM (TM)
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JHW
1988-06-08
IMPRES-MB
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JHW
1982-12-15
DSL 1700
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JHW
1981-06-25
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
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JHW
1981-06-25
CARDIOZYME PLUS CK-MB ITEM #65045
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JHW
1981-04-14
ISOMUNE-CK
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JHW
1981-04-14
CREATINE KINASE MB ISOENZYME IMMUNO UV
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JHW
1981-01-09
CARDIO ZYME PLUS CK-MB #65045
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JHW
1980-01-11
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
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JHW
1979-02-01
A-GENT CK-MB
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JHW
1978-08-10
CPK ISOENZYME REAGENT
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JHW
1977-12-06
DYNAZYME TM II CARDIAK-MB
View details →No matching devices.
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