The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Ast(got) (aspartate Aminotransferase) Reagent.
Device ID | K864357 |
510k Number | K864357 |
Device Name: | AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Contact | William C Riddle |
Correspondent | William C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-03 |
Decision Date | 1987-02-06 |