The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Dcl Syphilis-m Catalog No. 600-80.
| Device ID | K895964 |
| 510k Number | K895964 |
| Device Name: | DCL SYPHILIS-M CATALOG NO. 600-80 |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 160 CHRISTIAN ST. Oxford, CT 06478 |
| Contact | David Templeton |
| Correspondent | David Templeton DIAGNOSTIC CHEMICALS, LTD. (USA) 160 CHRISTIAN ST. Oxford, CT 06478 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1991-01-08 |