Name: Predicase
Price: 199 USD

K-number	K993250
Device name	THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
Applicant	Zeus Scientific, Inc.
Product code	MST
Device class	Class II
Decision date	Nov 12, 1999
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.

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