FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA SMAC REAGENTS
K Number: K790578
·
Decision May 15, 1979
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
23
Review Days
49
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Basic Information
- Device Name
- GAMMA SMAC REAGENTS
- K Number
- K790578
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Gamma Enterprises, Inc.
- Date Received
- March 27, 1979
- Decision Date
- May 15, 1979
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
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Other Clearances by Gamma Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | May 3, 1978 | Substantially Equivalent |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | 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 |