The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Autoimmunity Screening Panel 3.
| Device ID | K902938 |
| 510k Number | K902938 |
| Device Name: | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Bryan L Kiehl |
| Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-03 |
| Decision Date | 1990-08-09 |