FDA Product Code
FDA Product Code DAS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5530
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K982023 | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT | Inova Diagnostics, Inc. | 1998-09-04 | Traditional | PDF ↗ |
| K944876 | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | Research Diagnostics, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K943098 | HUMAN IGG SUBCLASSES ELISA COMBI KIT | Research Diagnostics, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K943205 | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | Research Diagnostics, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K895600 | HUMAN (IGG) SUBCLASS (EIA) KIT | The Binding Site, Ltd. | 1989-11-08 | Traditional | PDF ↗ |
| K790708 | ANTISERUM TO HUMAN IG G FC FRAGMENTS | Kent Laboratories, Inc. | 1979-08-22 | Traditional | PDF ↗ |
| K790715 | ANTISERUM TO HUMAN FC | Kent Laboratories, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K761156 | AMINOGLYCOSIDE CONTROLS | Supelco, Inc. | 1976-12-09 | Traditional | PDF ↗ |
Product code DAS · Class I · Immunology. Data: openFDA.