K942820 is an FDA 510(k) clearance for the H292. This device is classified as a Cells, Animal And Human, Cultured (Class I - General Controls, product code KIR).
Submitted by Bartels, Inc. (Issaquah, US). The FDA issued a Cleared decision on May 5, 1995, 324 days after receiving the submission on June 15, 1994.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2280.
| 510(k) Number | K942820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1994 |
| Decision Date | May 05, 1995 |
| Days to Decision | 324 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 |