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 |