K-number	K961142
Device name	STRATEC LIA II ANALYZER
Applicant	Nichols Institute Diagnostics
Product code	JJE
Device class	Class I
Decision date	Feb 18, 1997
Decision	Substantially Equivalent
Regulation	862.2160

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View the full FDA submission: accessdata.fda.gov

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STRATEC LIA II ANALYZER

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