The following data is part of a premarket notification filed by Allelix Diagnostics, Inc. with the FDA for Visuwell Reagin Test 960 Test Kit.
| Device ID | K885298 |
| 510k Number | K885298 |
| Device Name: | VISUWELL REAGIN TEST 960 TEST KIT |
| Classification | Antisera, Control For Nontreponemal Tests |
| Applicant | ALLELIX DIAGNOSTICS, INC. 6850 GOREWAY DR. MISSISSAUGA, ONTARIO Canada L4v 1p1, CA |
| Contact | Janet Shaw |
| Correspondent | Janet Shaw ALLELIX DIAGNOSTICS, INC. 6850 GOREWAY DR. MISSISSAUGA, ONTARIO Canada L4v 1p1, CA |
| Product Code | GMP |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-27 |
| Decision Date | 1989-03-15 |