The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Ast (got) Reagent.
Device ID | K922108 |
510k Number | K922108 |
Device Name: | KING DIAGNOSTICS AST (GOT) REAGENT |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
Contact | Frances Loh |
Correspondent | Frances Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-05 |
Decision Date | 1992-07-15 |