K871033 is an FDA 510(k) clearance for the RABBIT KIDNEY CULTURE CELLS (FIRST PASS). This device is classified as a Cells, Animal And Human, Cultured (Class I - General Controls, product code KIR).
Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on March 31, 1987, 15 days after receiving the submission on March 16, 1987.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2280.
| 510(k) Number | K871033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1987 |
| Decision Date | March 31, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIR — Cells, Animal And Human, Cultured |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2280 |