K-number	K891299
Device name	MID-LEVEL IGG KIT CAT. NO. 9315
Applicant	Helena Laboratories
Product code	DAQ
Device class	Class I
Decision date	Mar 22, 1989
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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MID-LEVEL IGG KIT CAT. NO. 9315

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