FDA 510(k)
Substantially Equivalent
🇺🇸 United States
WETTING AGENTS
K Number: K771843
·
Decision Nov 22, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
23
Review Days
62
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Basic Information
- Device Name
- WETTING AGENTS
- K Number
- K771843
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Gamma Enterprises, Inc.
- Date Received
- September 21, 1977
- Decision Date
- November 22, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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 |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | May 3, 1978 | Substantially Equivalent |
| K780506 | CARBON DIOXIDE REAGENTS | May 3, 1978 | 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 |