The following data is part of a premarket notification filed by Meloy Laboratories, Inc. with the FDA for Anti-nuclear Antibody Test.
Device ID | K791493 |
510k Number | K791493 |
Device Name: | ANTI-NUCLEAR ANTIBODY TEST |
Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | MELOY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DHN |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-02 |
Decision Date | 1979-09-24 |