K-number	K892224
Device name	D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
Applicant	Photec Diagnostics, Inc.
Product code	KHQ
Device class	Class II
Decision date	Jun 16, 1989
Decision	Substantially Equivalent
Regulation	862.1715

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View the full FDA submission: accessdata.fda.gov

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D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN

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