DAO
8 FDA 510(k) clearances · Product code
42 daysmedian time to decision
98 days90th percentile
8clearances measured
FDA profile
- Official device name
- Igm (Mu Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2001: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 (K040431) | Roche Diagnostics Corp. | 2004-03-10 |
| SPIFE URINE IFE (K982639) | Helena Laboratories | 1998-11-04 |
| BOEHRINGER MANNHEIM IGM ASSAY (K955908) | Boehringer Mannheim Corp. | 1996-02-09 |
| SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (K850586) | Applications Lab | 1985-03-14 |
| MODIFICATION TO ACS CORONARY GUIDING (K841992) | Advanced Cardiovascular Systems, Inc. | 1984-06-11 |
| IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM (K812487) | Dako Corp. | 1981-09-23 |
| GEMENI IGM ASSAY (K800450) | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 |
| ANTISERUM TO HUMAN IGM (K790705) | Kent Laboratories, Inc. | 1979-04-12 |
Track DAO automatically
Every clearance here is in the API, with alerts when new ones post.