K962294 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM. This device is classified as a Nephelometer, For Clinical Use (Class I - General Controls, product code JQX).
Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 21, 1996, 68 days after receiving the submission on June 14, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2700.
| 510(k) Number | K962294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1996 |
| Decision Date | August 21, 1996 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JQX — Nephelometer, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2700 |