K811001 is an FDA 510(k) clearance for the MICROERMA SYSTEM. This device is classified as a Station, Pipetting And Diluting, For Clinical Use (Class I - General Controls, product code JQW).
Submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981, 18 days after receiving the submission on April 13, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2750.
| 510(k) Number | K811001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1981 |
| Decision Date | May 01, 1981 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JQW — Station, Pipetting And Diluting, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2750 |