DeviceClearance

ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227— 510(k) K061382

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K061382 for ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227, Substantially Equivalent on 2006-07-06. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code JZO
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, US
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