FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CK
K Number: K983070
·
Decision Feb 16, 1999
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
122
Applicant Total
883
Review Days
167
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Basic Information
- Device Name
- CK
- K Number
- K983070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- September 2, 1998
- Decision Date
- February 16, 1999
- Product Code
- CGS
- 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 |
|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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