K780305 is an FDA 510(k) clearance for the CELL. This device is classified as a System, Suspension, Cell Culture (Class I - General Controls, product code KJF).
Submitted by Dynatech Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1978, 32 days after receiving the submission on February 23, 1978.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K780305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1978 |
| Decision Date | March 27, 1978 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KJF — System, Suspension, Cell Culture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2240 |