K891269 is an FDA 510(k) clearance for the MICROTRAK EIA AUTOWASHER. This device is classified as a Cannula, Ear (Class I - General Controls, product code JYC).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 1, 1989, 53 days after receiving the submission on March 9, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K891269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1989 |
| Decision Date | May 01, 1989 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JYC — Cannula, Ear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |