K-number	K821934
Device name	BIO-CAL OPERATION CHECK KIT
Applicant	Bio-Analytics Laboratories, Inc.
Product code	JIS
Device class	Class II
Decision date	Jul 20, 1982
Decision	Substantially Equivalent
Regulation	862.1150

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View the full FDA submission: accessdata.fda.gov

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BIO-CAL OPERATION CHECK KIT

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