K843088 is an FDA 510(k) clearance for the EBA 3 S CENTRIFUGE. This device is classified as a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I - General Controls, product code JQC).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on August 29, 1984, 23 days after receiving the submission on August 6, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K843088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1984 |
| Decision Date | August 29, 1984 |
| Days to Decision | 23 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 |