K890908 is an FDA 510(k) clearance for the STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES. 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 March 24, 1989, 29 days after receiving the submission on February 23, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2560.
| 510(k) Number | K890908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1989 |
| Decision Date | March 24, 1989 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2560 |