K-number	K893676
Device name	ABBOTT TESTPACK CHLAMYDIA
Applicant	Abbott Laboratories
Product code	LJC
Device class	Class I
Decision date	Jul 25, 1989
Decision	Substantially Equivalent
Regulation	866.3120

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View the full FDA submission: accessdata.fda.gov

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ABBOTT TESTPACK CHLAMYDIA

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