The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Ultraviolet Alanine Amino-trans (uv-alt/uv-gpt).
Device ID | K871782 |
510k Number | K871782 |
Device Name: | ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) |
Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
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 | CKA |
CFR Regulation Number | 862.1030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-06 |
Decision Date | 1987-05-26 |