Submission Details
| 510(k) Number | K821687 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 08, 1982 |
| Decision Date | June 24, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K821687 is an FDA 510(k) clearance for the REMOVAWELL TISSUE CULTURE PLATE W/LID, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982, 16 days after receiving the submission on June 8, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K821687 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 08, 1982 |
| Decision Date | June 24, 1982 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KIZ — Dish, Tissue Culture |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2240 |