K-number	K061190
Device name	ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
Applicant	Beckman Coulter, Inc.
Product code	CEW
Device class	Class II
Decision date	Sep 15, 2006
Decision	Substantially Equivalent
Regulation	862.1545

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View the full FDA submission: accessdata.fda.gov

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ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

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