K-number	K871278
Device name	MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT
Applicant	California Integrated Diagnostics, Inc.
Product code	LJP
Device class	Class I
Decision date	Apr 8, 1987
Decision	Substantially Equivalent
Regulation	866.3120

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View the full FDA submission: accessdata.fda.gov

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MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT

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