The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Sjogrens Syndrome A (ro)antibody Test.
| Device ID | K911849 |
| 510k Number | K911849 |
| Device Name: | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST |
| Classification | Anti-rnp Antibody, Antigen And Control |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | L.kiehl Phd. |
| Correspondent | L.kiehl Phd. GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | LKO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-26 |
| Decision Date | 1991-05-07 |