K911849 is an FDA 510(k) clearance for the IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST. This device is classified as a Anti-rnp Antibody, Antigen And Control (Class II - Special Controls, product code LKO).
Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on May 7, 1991, 11 days after receiving the submission on April 26, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K911849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1991 |
| Decision Date | May 07, 1991 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKO — Anti-rnp Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |