K-number	K883767
Device name	LYME DISEASE IFA (IGM)
Applicant	Hillcrest Biologicals
Product code	LSR
Device class	Class II
Decision date	Mar 15, 1989
Decision	Substantially Equivalent
Regulation	866.3830

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View the full FDA submission: accessdata.fda.gov

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LYME DISEASE IFA (IGM)

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