K933927 is an FDA 510(k) clearance for the HEP-2 CULTURE CELL. This device is classified as a Cells, Animal And Human, Cultured (Class I — General Controls, product code KIR).
Submitted by Neogenex (Everett, US). The FDA issued a Cleared decision on March 31, 1994, 233 days after receiving the submission on August 10, 1993.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2280.
| 510(k) Number | K933927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1993 |
| Decision Date | March 31, 1994 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | KIR — Cells, Animal And Human, Cultured |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2280 |