The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Anti-nuclear Antibody Test Kit (ana).
| Device ID | K822681 |
| 510k Number | K822681 |
| Device Name: | ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | AMICO LAB, 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 | 1982-09-03 |
| Decision Date | 1982-12-13 |