K801481 is an FDA 510(k) clearance for the BMC RIAFLO SYSTEM. This device is classified as a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I - General Controls, product code JJC).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980, 57 days after receiving the submission on June 24, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2150.
| 510(k) Number | K801481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1980 |
| Decision Date | August 20, 1980 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJC — Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2150 |