K913130 is an FDA 510(k) clearance for the STRATUS IINTELLECT IMMUNOASSAY SYSTEM. This device is classified as a Fluorometer, For Clinical Use (Class I - General Controls, product code KHO).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on September 27, 1991, 73 days after receiving the submission on July 16, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K913130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 1991 |
| Decision Date | September 27, 1991 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2560 |