510(k) K780507
K780507 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "SERUM GLUTAMIC-PYRUVIC TRANSAMINASE". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code CKC (Vanillin Pyruvate, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1978
- Date Received
- March 30, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vanillin Pyruvate, Alt/Sgpt
- Device Class
- Class I
- Regulation Number
- 862.1030
- Review Panel
- CH
- Submission Type