K-number	K821964
Device name	125I QUICK-MB TEST KIT FOR QUANTITATION
Applicant	Intl. Immunoassay Laboratories, Inc.
Product code	JHT
Device class	Class II
Decision date	Jul 22, 1982
Decision	Substantially Equivalent
Regulation	862.1215

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125I QUICK-MB TEST KIT FOR QUANTITATION

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