K895582 is an FDA 510(k) clearance for the QCLYTE PROTEIN-BASED ISE CONTROL. This device is classified as a Electrolyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJR).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on October 4, 1989, 19 days after receiving the submission on September 15, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K895582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 1989 |
| Decision Date | October 04, 1989 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJR — Electrolyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |