Name: Predicase
Price: 199 USD

K-number	K013145
Device name	WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
Applicant	Wiener Laboratories Saic
Product code	CIT
Device class	Class II
Decision date	Nov 27, 2001
Decision	Substantially Equivalent
Regulation	862.1100

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Source

View the full FDA submission: accessdata.fda.gov

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WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.

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