PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
FDA 510(k) clearance K020823 · decided 2002-05-14
Clearance details
- K-number
- K020823
- Device name
- PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
- Applicant
- Sanquin Blood Supply Foundation
- Decision
- Substantially Equivalent
- Date received
- 2002-03-14
- Decision date
- 2002-05-14
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- DFZ
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.