Name: Predicase
Price: 199 USD

K-number	K933934
Device name	GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
Applicant	Sigma Diagnostics, Inc.
Product code	JBF
Device class	Class II
Decision date	Jun 29, 1995
Decision	Substantially Equivalent
Regulation	864.7360

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Source

View the full FDA submission: accessdata.fda.gov

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GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A

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