The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Autoimmune Screening Panel 1.
| Device ID | K896347 |
| 510k Number | K896347 |
| Device Name: | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Kiehl, Phd |
| Correspondent | Kiehl, Phd GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-03 |
| Decision Date | 1989-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745051895 | K896347 | 000 |
| 00613745051253 | K896347 | 000 |
| 00613745039206 | K896347 | 000 |
| 00613745039183 | K896347 | 000 |