Atlas FDA

BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

FDA 510(k) clearance K062213 · decided 2006-12-08

Clearance details

K-number
K062213
Device name
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Applicant
Bio-Rad Laboratories, Inc.
Decision
Substantially Equivalent
Date received
2006-08-01
Decision date
2006-12-08
Days to decision
129 days
Clearance type
Traditional
Product code
LSE
Device class
1
Regulation number
866.3235
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 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - ma recall (Z-1158-2008)Bio-Rad Laboratories2008-06-11

PMA approvals by this applicant

RecordFirmDate
MONOLISA ANTI-HBC IGM EIA (P060034/S008)Bio-Rad Laboratories, Inc.2014-03-19
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007)Bio-Rad Laboratories, Inc.2013-12-12
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007)Bio-Rad Laboratories, Inc.2013-12-12
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006)Bio-Rad Laboratories, Inc.2012-11-13
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006)Bio-Rad Laboratories, Inc.2012-11-13
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005)Bio-Rad Laboratories, Inc.2011-04-28
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003)Bio-Rad Laboratories, Inc.2010-12-30
MONOLISA ANTI-HBC IGM EIA (P060034/S005)Bio-Rad Laboratories, Inc.2010-11-23