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FDA 510(k), K940422, IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
FDA 510(k), K940422, IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
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510(K) Number: K940422
Device Name: IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
Manufacturer: THE BINDING SITE, LTD.
Device Classification Name: igg (gamma chain specific), antigen, antiserum, control
Regulation Number: 866.5510
Classification Product Code: DFZ
Date Received: 01/19/1994
Decision Date: 05/27/1994
Regulation Medical Specialty: Immunology
Device Name: IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
Manufacturer: THE BINDING SITE, LTD.
Device Classification Name: igg (gamma chain specific), antigen, antiserum, control
Regulation Number: 866.5510
Classification Product Code: DFZ
Date Received: 01/19/1994
Decision Date: 05/27/1994
Regulation Medical Specialty: Immunology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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