FDA Data MCP
☰
Docs
Datasets
Pricing
Blog
Account
Statistics
Get API Key
Home
/
510(k) Clearances
/ K771843
510(k) K771843
WETTING AGENTS by
Gamma Enterprises, Inc.
Clearance Details
Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
September 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No
Other clearances by Gamma Enterprises, Inc.
K790578
— GAMMA SMAC REAGENTS (May 15, 1979)
K780506
— CARBON DIOXIDE REAGENTS (May 3, 1978)
K780507
— SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
K780504
— CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
K780505
— SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
K771832
— CHLORIDE (November 22, 1977)
K771836
— LACTATE DEHYDROGENASE (November 22, 1977)
K771838
— SERUM IRON (November 3, 1977)
K771834
— CREATININE (November 3, 1977)
K771837
— POTASSIUM (November 2, 1977)