The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Immuknow-check Hcg Assay Kit, Cat. #900-40.
| Device ID | K883148 |
| 510k Number | K883148 |
| Device Name: | IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Regis Duffy |
| Correspondent | Regis Duffy DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-12-05 |