DFZ
9 FDA 510(k) clearances · Product code
75 daysmedian time to decision
128 days90th percentile
9clearances measured
FDA profile
- Official device name
- Igg (Gamma Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG (K092283) | Siemens Healthcare Diagnostics | 2009-10-21 |
| HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER (K021081) | The Binding Site, Ltd. | 2002-06-17 |
| PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (K020823) | Sanquin Blood Supply Foundation | 2002-05-14 |
| BOEHRINGER MANNHEIM IGG ASSAY (K955906) | Boehringer Mannheim Corp. | 1996-02-09 |
| IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER (K940422) | The Binding Site, Ltd. | 1994-05-27 |
| H-103 IGG, H-104 IGA, H-105 IGM (K812821) | Immulok, Inc. | 1981-10-26 |
| AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (K803272) | Icl Scientific | 1981-01-26 |
| ANTISERA TO RABBIT IMMUNOGLOBULIN (K790720) | Kent Laboratories, Inc. | 1979-08-16 |
| ANTISERUM TO RABBIT IMMUNOGLOBULIN (K790709) | Kent Laboratories, Inc. | 1979-08-16 |
Track DFZ automatically
Every clearance here is in the API, with alerts when new ones post.