The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Alt(gpt) (alanine Aminotransferase) Reagent.
Device ID | K860727 |
510k Number | K860727 |
Device Name: | ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT |
Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Contact | W. C Riddle |
Correspondent | W. C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
Product Code | CKA |
CFR Regulation Number | 862.1030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-04-07 |