510(k) K940422
- Device
- IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K940422
- Product code
- DFZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-27
- Date received
- 1994-01-19
- Regulation
- 866.5510
- Classification name
- Igg (gamma Chain Specific), Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- East Tower, Suite 600 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 9610806
- 3019906
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DFZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | Siemens Healthcare Diagnostics | 2009-10-21 |
| K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | The Binding Site, Ltd. | 2002-06-17 |
| K020823 | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | Sanquin Blood Supply Foundation | 2002-05-14 |
| K955906 | BOEHRINGER MANNHEIM IGG ASSAY | Boehringer Mannheim Corp. | 1996-02-09 |
| K812821 | H-103 IGG, H-104 IGA, H-105 IGM | Immulok, Inc. | 1981-10-26 |
| K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | Icl Scientific | 1981-01-26 |
| K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | 1979-08-16 |
| K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN | Kent Laboratories, Inc. | 1979-08-16 |
Legacy Summary#
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FDA Review#
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