K871290 is an FDA 510(k) clearance for the CENTRICELL(TM). This device is classified as a Clinical Sample Concentrator (Class I - General Controls, product code JJH).
Submitted by Polysciences, Inc. (Warrington, US). The FDA issued a Cleared decision on August 5, 1987, 127 days after receiving the submission on March 31, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2310.
| 510(k) Number | K871290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1987 |
| Decision Date | August 05, 1987 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJH — Clinical Sample Concentrator |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2310 |