FDA Product Code
FDA Product Code DAO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5550
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040431 | ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 | Roche Diagnostics Corp. | 2004-03-10 | Special | PDF ↗ |
| K982639 | SPIFE URINE IFE | Helena Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K955908 | BOEHRINGER MANNHEIM IGM ASSAY | Boehringer Mannheim Corp. | 1996-02-09 | Traditional | PDF ↗ |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | Applications Lab | 1985-03-14 | Traditional | PDF ↗ |
| K841992 | MODIFICATION TO ACS CORONARY GUIDING | Advanced Cardiovascular Systems, Inc. | 1984-06-11 | Traditional | PDF ↗ |
| K812487 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K800450 | GEMENI IGM ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 | Traditional | PDF ↗ |
| K790705 | ANTISERUM TO HUMAN IGM | Kent Laboratories, Inc. | 1979-04-12 | Traditional | PDF ↗ |
Product code DAO · Class II · Immunology. Data: openFDA.