K890542 is an FDA 510(k) clearance for the MULTIWELL CULTURE PLATE INSERTS. This device is classified as a Dish, Tissue Culture (Class I - General Controls, product code KIZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 14, 1989, 11 days after receiving the submission on February 3, 1989.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K890542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 1989 |
| Decision Date | February 14, 1989 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIZ — Dish, Tissue Culture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2240 |