The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Ultraviolet Aspartate Amino-trans (uv-ast/uv-got).
| Device ID | K871780 |
| 510k Number | K871780 |
| Device Name: | ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
| Contact | Roy, Ph.d. |
| Correspondent | Roy, Ph.d. BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-06 |
| Decision Date | 1987-06-04 |