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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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