The following data is part of a premarket notification filed by Breit Laboratories, Inc. with the FDA for Antinuclear Antibody Test Kit.
| Device ID | K831927 |
| 510k Number | K831927 |
| Device Name: | ANTINUCLEAR ANTIBODY TEST KIT |
| Classification | Igg, Peroxidase, Antigen, Antiserum, Control |
| Applicant | BREIT LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DAA |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-15 |
| Decision Date | 1983-07-18 |