510(k) K780507
- Device
- SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
- Applicant
- GAMMA ENTERPRISES, INC.
- 510(k) number
- K780507
- Product code
- CKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-03
- Date received
- 1978-03-30
- Regulation
- 862.1030
- Classification name
- Vanillin Pyruvate, Alt/sgpt
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CKC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832791 | SERAYZER ALT/SGPT REAGENT STRIPS | Miles Laboratories, Inc. | 1983-10-14 |
Legacy Summary#
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FDA Review#
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