K911834 is an FDA 510(k) clearance for the OPUS(R) ROZO. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on August 12, 1991, 109 days after receiving the submission on April 25, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K911834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1991 |
| Decision Date | August 12, 1991 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |