The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Emds Aspartate Aminotransferase Item Number 65405.
Device ID | K893692 |
510k Number | K893692 |
Device Name: | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Contact | Anna Bentley |
Correspondent | Anna Bentley DIAGNOSTIC SYSTEMS 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-16 |
Decision Date | 1989-08-21 |