K842833 is an FDA 510(k) clearance for the PMK PRIMARY MONKEY KIDNEY-CELLS. This device is classified as a Erythrosin B (Class I - General Controls, product code KJR).
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 39 days after receiving the submission on July 20, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K842833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1984 |
| Decision Date | August 28, 1984 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KJR — Erythrosin B |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |