The following data is part of a premarket notification filed by Immco Diagnostics, Inc. with the FDA for Lupus(le)-latex Test.
| Device ID | K905531 |
| 510k Number | K905531 |
| Device Name: | LUPUS(LE)-LATEX TEST |
| Classification | Antisera, Fluorescent, Chlamydia Spp. |
| Applicant | IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Contact | Susan Krasny |
| Correspondent | Susan Krasny IMMCO DIAGNOSTICS, INC. 963 KENMORE AVE. Buffalo, NY 14223 |
| Product Code | LKI |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-10 |
| Decision Date | 1991-01-25 |