The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Lactane Dehydrogenase-sl Assay, Catalogue Number 327-10, 327-30.
| Device ID | K974859 |
| 510k Number | K974859 |
| Device Name: | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-29 |
| Decision Date | 1998-01-22 |