The following data is part of a premarket notification filed by Carolina Liquid Chemistries Corp. with the FDA for Ast Or Sgot.
Device ID | K971344 |
510k Number | K971344 |
Device Name: | AST OR SGOT |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 Brea, CA 92821 |
Contact | Cynthia Shugart |
Correspondent | Cynthia Shugart CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 Brea, CA 92821 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-10 |
Decision Date | 1997-04-21 |