Atlas FDA

ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05

FDA 510(k) clearance K984070 · decided 1998-11-25

Clearance details

K-number
K984070
Device name
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
Applicant
Bio-Rad
Decision
Substantially Equivalent
Date received
1998-11-16
Decision date
1998-11-25
Days to decision
9 days
Clearance type
Traditional
Product code
JJX
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed recall (Z-1569-2008)Abbott Laboratories2008-07-31

PMA approvals by this applicant

RecordFirmDate
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002)Bio-Rad1996-03-01
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001)Bio-Rad1991-03-14
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032)Bio-Rad1989-07-24