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Biosensor, Immunoassay, Cpk Or Isoenzymes

FDA product code MYT · 3 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
1999-11-01 – 2005-12-15
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