The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Dc-lip, Catalogue Number Se-020.
| Device ID | K852594 |
| 510k Number | K852594 |
| Device Name: | DC-LIP, CATALOGUE NUMBER SE-020 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-19 |
| Decision Date | 1985-07-12 |