FDA Product Code
FDA Product Code DFZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | Siemens Healthcare Diagnostics | 2009-10-21 | Traditional | PDF ↗ |
| K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | The Binding Site, Ltd. | 2002-06-17 | Traditional | PDF ↗ |
| K020823 | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | Sanquin Blood Supply Foundation | 2002-05-14 | Traditional | PDF ↗ |
| K955906 | BOEHRINGER MANNHEIM IGG ASSAY | Boehringer Mannheim Corp. | 1996-02-09 | Traditional | PDF ↗ |
| K940422 | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | The Binding Site, Ltd. | 1994-05-27 | Traditional | PDF ↗ |
| K812821 | H-103 IGG, H-104 IGA, H-105 IGM | Immulok, Inc. | 1981-10-26 | Traditional | PDF ↗ |
| K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | Icl Scientific | 1981-01-26 | Traditional | PDF ↗ |
| K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | 1979-08-16 | Traditional | PDF ↗ |
Product code DFZ · Class II · Immunology. Data: openFDA.