The following data is part of a premarket notification filed by Jas Diagnostics, Inc. with the FDA for Ast (sgot).
Device ID | K013698 |
510k Number | K013698 |
Device Name: | AST (SGOT) |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
Contact | David Johnston |
Correspondent | David Johnston JAS Diagnostics, Inc. 7220 NW 58TH ST. Miami, FL 33166 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-07 |
Decision Date | 2001-12-21 |