K883349 is an FDA 510(k) clearance for the QLIA IMMUNOCHEMISTRY SYSTEM. This device is classified as a Fluorometer (Class I - General Controls, product code JZT).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 7, 1988, 29 days after receiving the submission on August 9, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4520.
| 510(k) Number | K883349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1988 |
| Decision Date | September 07, 1988 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZT — Fluorometer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4520 |