The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Anazyme Ana Peroxidase Test System.
| Device ID | K822911 |
| 510k Number | K822911 |
| Device Name: | ANAZYME ANA PEROXIDASE TEST SYSTEM |
| Classification | Igg, Peroxidase, Antigen, Antiserum, Control |
| Applicant | CLINICAL SCIENCES, 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 | 1982-10-01 |
| Decision Date | 1982-10-22 |