K885263 is an FDA 510(k) clearance for the QMS(TM) - THEOPHYLLINE. This device is classified as a Nephelometer, For Clinical Use (Class I - General Controls, product code JQX).
Submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 28, 1989, 95 days after receiving the submission on December 23, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2700.
| 510(k) Number | K885263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1988 |
| Decision Date | March 28, 1989 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQX — Nephelometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2700 |