FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
K Number: K940422
·
Decision May 27, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
115
Review Days
128
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Basic Information
- Device Name
- IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
- K Number
- K940422
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Binding Site, Ltd.
- Date Received
- January 19, 1994
- Decision Date
- May 27, 1994
- Product Code
- DFZ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DFZ | Igg (Gamma Chain Specific), Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | Dec 19, 2008 | Substantially Equivalent |
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| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | Jun 6, 2008 | Substantially Equivalent |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | Feb 1, 2008 | Substantially Equivalent |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | Nov 30, 2007 | Substantially Equivalent |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | Jun 21, 2007 | Substantially Equivalent |