The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for The Turbox Analyser System Complement C3 And C4.
| Device ID | K890675 |
| 510k Number | K890675 |
| Device Name: | THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Mr. G Zajicek |
| Correspondent | Mr. G Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-03-06 |