FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATINE KINASE REAGENT
K Number: K980012
·
Decision Feb 25, 1998
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
47
Applicant Total
3
Review Days
54
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Basic Information
- Device Name
- CREATINE KINASE REAGENT
- K Number
- K980012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ac Biochemicals, Inc.
- Date Received
- January 2, 1998
- Decision Date
- February 25, 1998
- Product Code
- JHX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JHX | Fluorometric Method, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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