K984437 is an FDA 510(k) clearance for the QUANTEX ASO-CRP-RP CONTROL II. This device is classified as a Enzyme Controls (assayed And Unassayed) (Class I - General Controls, product code JJT).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on February 2, 1999, 50 days after receiving the submission on December 14, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K984437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1998 |
| Decision Date | February 02, 1999 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJT — Enzyme Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |