K-number	K895745
Device name	SICKLE CELL SOLUBILITY TEST KIT
Applicant	Simmler, Inc.
Product code	JBB
Device class	Class II
Decision date	Nov 29, 1989
Decision	Substantially Equivalent
Regulation	864.7825

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View the full FDA submission: accessdata.fda.gov

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SICKLE CELL SOLUBILITY TEST KIT

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