Submission Details
| 510(k) Number | K864974 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 19, 1986 |
| Decision Date | January 09, 1987 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K864974 is an FDA 510(k) clearance for the GENERAL PURPOSE CENTRIFUGE, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Norfolk Scientific, Inc. (Norwood, US). The FDA issued a Cleared decision on January 9, 1987, 21 days after receiving the submission on December 19, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K864974 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 19, 1986 |
| Decision Date | January 09, 1987 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2050 |