K955908 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM IGM ASSAY. This device is classified as a Igm (mu Chain Specific), Antigen, Antiserum, Control (Class II - Special Controls, product code DAO).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 9, 1996, 42 days after receiving the submission on December 29, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K955908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1995 |
| Decision Date | February 09, 1996 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DAO — Igm (mu Chain Specific), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |