K-number	K900422
Device name	TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
Applicant	Helena Laboratories
Product code	CZP
Device class	Class II
Decision date	Feb 27, 1990
Decision	Substantially Equivalent
Regulation	866.5510

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View the full FDA submission: accessdata.fda.gov

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TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046

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