Atlas FDA

MODIFICATION TO ABL800 FLEX

FDA 510(k) clearance K050869 · decided 2005-08-11

Clearance details

K-number
K050869
Device name
MODIFICATION TO ABL800 FLEX
Applicant
Radiometer Medical Aps
Decision
Substantially Equivalent
Date received
2005-04-06
Decision date
2005-08-11
Days to decision
127 days
Clearance type
Special
Product code
CIG
Device class
2
Regulation number
862.1110
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex B recall (Z-0115-2007)Radiometer America Inc2006-10-28