K-number	K860945
Device name	DIRECTACLONE CG SLIDE PREGNANCY TEST
Applicant	Pacific Biotech, Inc.
Product code	JHJ
Device class	Class II
Decision date	May 2, 1986
Decision	Substantially Equivalent
Regulation	862.1155

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View the full FDA submission: accessdata.fda.gov

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DIRECTACLONE CG SLIDE PREGNANCY TEST

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