K901141 is an FDA 510(k) clearance for the PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX. This device is classified as a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I - General Controls, product code JJC).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 9, 1990, 27 days after receiving the submission on March 13, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2150.
| 510(k) Number | K901141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 1990 |
| Decision Date | April 09, 1990 |
| Days to Decision | 27 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 |