Atlas FDA

ARCHITECT CA 19-9XR ASSAY

FDA 510(k) clearance K052000 · decided 2005-10-25

Clearance details

K-number
K052000
Device name
ARCHITECT CA 19-9XR ASSAY
Applicant
Fujirebio Diagnostics,Inc.
Decision
Substantially Equivalent
Date received
2005-07-25
Decision date
2005-10-25
Days to decision
92 days
Clearance type
Traditional
Product code
NIG
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Malvern, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests recall (Z-1904-2012)Abbott Laboratories2012-06-29