DeviceClearance

ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316— 510(k) K000196

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K000196 for ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316, Substantially Equivalent on 2000-02-18. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant
Beckman Coulter, Inc.
Product code
Code DDR
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chaska, MN, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.