K955798 is an FDA 510(k) clearance for the IGG IMMUNOTURBIDIMETRIC & CALIBRATOR. This device is classified as a Igg, Antigen, Antiserum, Control (Class II - Special Controls, product code DEW).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on April 5, 1996, 105 days after receiving the submission on December 22, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K955798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1995 |
| Decision Date | April 05, 1996 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEW — Igg, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |