Submission Details
| 510(k) Number | K871483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 15, 1987 |
| Decision Date | April 29, 1987 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K871483 is an FDA 510(k) clearance for the TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Isratech Marketing Corp. (New York, US). The FDA issued a Cleared decision on April 29, 1987, 14 days after receiving the submission on April 15, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K871483 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 15, 1987 |
| Decision Date | April 29, 1987 |
| Days to Decision | 14 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 |