Name: Predicase
Price: 199 USD

K-number	K971591
Device name	INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)
Applicant	David C. Bishop, Ph.D.
Product code	LSQ
Device class	Class I
Decision date	Mar 13, 1998
Decision	Substantially Equivalent
Regulation	866.3500

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INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)

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