Name: Predicase
Price: 199 USD

K-number	K991707
Device name	MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
Applicant	Beckman
Product code	DHX
Device class	Class II
Decision date	Jun 1, 1999
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

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