The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Triglyceride-sl Assay Catalogue No. 236-60.
| Device ID | K961281 |
| 510k Number | K961281 |
| Device Name: | TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| 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 | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1996-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400911 | K961281 | 000 |
| 00628063400904 | K961281 | 000 |
| 00628063400898 | K961281 | 000 |