K780388 is an FDA 510(k) clearance for the ANALYZER, 100, BICHROMATIC, ABBOTT. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I - General Controls, product code JJE).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1978, 12 days after receiving the submission on March 10, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.2160.
| 510(k) Number | K780388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1978 |
| Decision Date | March 22, 1978 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2160 |