K962201 is an FDA 510(k) clearance for the QUANTEX IGM. This device is classified as a Igm, Antigen, Antiserum, Control (Class II - Special Controls, product code DFT).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 25, 1996, 110 days after receiving the submission on June 7, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K962201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1996 |
| Decision Date | September 25, 1996 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DFT — Igm, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |