K-number	K982426
Device name	SPIFE ALKALINE HEMOGLOBIN
Applicant	Helena Laboratories
Product code	JBD
Device class	Class II
Decision date	Dec 17, 1998
Decision	Substantially Equivalent
Regulation	864.7440

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View the full FDA submission: accessdata.fda.gov

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SPIFE ALKALINE HEMOGLOBIN

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