Name: Predicase
Price: 199 USD

K-number	K940422
Device name	IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
Applicant	The Binding Site, Ltd.
Product code	DFZ
Device class	Class II
Decision date	May 27, 1994
Decision	Substantially Equivalent
Regulation	866.5510

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Source

View the full FDA submission: accessdata.fda.gov

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IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER

Everything you need for a 510(k) submission. Nothing you don't.