The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Aspartate Aminotransferase-sl Assay, Catalogue Number 319-10, 319-30.
Device ID | K974001 |
510k Number | K974001 |
Device Name: | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 |
Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
Contact | Karen Callbeck |
Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
Product Code | CIT |
CFR Regulation Number | 862.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-21 |
Decision Date | 1997-11-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628063400157 | K974001 | 000 |
00628063400140 | K974001 | 000 |