K-number	K892818
Device name	REP(TM) LD-2 STAT KIT, CAT. NO. 3078
Applicant	Helena Laboratories
Product code	CFE
Device class	Class II
Decision date	Jun 20, 1989
Decision	Substantially Equivalent
Regulation	862.1445

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View the full FDA submission: accessdata.fda.gov

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REP(TM) LD-2 STAT KIT, CAT. NO. 3078

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