K-number	K881898
Device name	MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B
Applicant	Atlantic Antibodies
Product code	MSJ
Device class	Class I
Decision date	Jun 14, 1988
Decision	Substantially Equivalent
Regulation	862.1475

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MODIFIED SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B

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