K926131 is an FDA 510(k) clearance for the OPUS MAGNUM ANALYZER. This device is classified as a Fluorometer, For Clinical Use (Class I - General Controls, product code KHO).
Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on June 7, 1993, 182 days after receiving the submission on December 7, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K926131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1992 |
| Decision Date | June 07, 1993 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2560 |