Atlas FDA

BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k) clearance K063866 · decided 2007-03-19

Clearance details

K-number
K063866
Device name
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
Bio-Rad Laboratories
Decision
Substantially Equivalent
Date received
2006-12-29
Decision date
2007-03-19
Days to decision
80 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Redmond, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad recall (Z-1156-2008)Bio-Rad Laboratories2008-06-11
BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet recall (Z-0256-2008)Bio-Rad Labroatories Inc.2007-11-09

PMA approvals by this applicant

RecordFirmDate
MONOLISA ANTI-HBS EIA (P050048/S010)Bio-Rad Laboratories2025-04-18
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S009)Bio-Rad Laboratories2013-12-12
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S008)Bio-Rad Laboratories2012-11-13
BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S007)Bio-Rad Laboratories2012-11-13
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S004)Bio-Rad Laboratories2011-04-25
MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S005)Bio-Rad Laboratories2010-11-23
BIO-RAD MONOLISA ANTI -HBS EIA (P050048/S006)Bio-Rad Laboratories2010-09-27
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