FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREATINE PHOSPHOKINASE (CPK)
K Number: K780504
·
Decision May 3, 1978
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
37
Applicant Total
23
Review Days
34
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Basic Information
- Device Name
- CREATINE PHOSPHOKINASE (CPK)
- K Number
- K780504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gamma Enterprises, Inc.
- Date Received
- March 30, 1978
- Decision Date
- May 3, 1978
- Product Code
- JHS
- 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 |
|---|---|---|---|
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by Gamma Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790578 | GAMMA SMAC REAGENTS | May 15, 1979 | Substantially Equivalent |
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780506 | CARBON DIOXIDE REAGENTS | May 3, 1978 | Substantially Equivalent |
| K771843 | WETTING AGENTS | Nov 22, 1977 | Substantially Equivalent |
| K771832 | CHLORIDE | Nov 22, 1977 | Substantially Equivalent |
| K771836 | LACTATE DEHYDROGENASE | Nov 22, 1977 | Substantially Equivalent |
| K771834 | CREATININE | Nov 3, 1977 | Substantially Equivalent |
| K771838 | SERUM IRON | Nov 3, 1977 | Substantially Equivalent |
| K771829 | ALKALINE PHOSPHATASE | Nov 2, 1977 | Substantially Equivalent |