K945522 is an FDA 510(k) clearance for the I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS. This device is classified as a Igm, Antigen, Antiserum, Control (Class II - Special Controls, product code DFT).
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on December 12, 1994, 32 days after receiving the submission on November 10, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K945522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1994 |
| Decision Date | December 12, 1994 |
| Days to Decision | 32 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 |