The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Alt/sgpt.
| Device ID | K965134 |
| 510k Number | K965134 |
| Device Name: | ALT/SGPT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Contact | Charles C Allain, Ph.d. |
| Correspondent | Charles C Allain, Ph.d. DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-02-18 |