K-number	K980314
Device name	FETAL D TECTION KIT
Applicant	Biopool Intl., Inc.
Product code	LIM
Device class	Class II
Decision date	Apr 8, 1998
Decision	Substantially Equivalent
Regulation	864.7455

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View the full FDA submission: accessdata.fda.gov

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FETAL D TECTION KIT

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