Submission Details
| 510(k) Number | K810951 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1981 |
| Decision Date | April 23, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K810951 is an FDA 510(k) clearance for the REAGENTS FOR QUANT. ENZYMATIC DETER.-TR., submitted by Mid Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 16 days after receiving the submission on April 7, 1981. This device falls under the Chemistry review panel.
| 510(k) Number | K810951 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1981 |
| Decision Date | April 23, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | — |
| Device Class | — |