Atlas FDA

MODIFICATION TO SERAQUEST EB VCA IGG

FDA 510(k) clearance K033915 · decided 2004-01-16

Clearance details

K-number
K033915
Device name
MODIFICATION TO SERAQUEST EB VCA IGG
Applicant
Quest Intl., Inc.
Decision
Substantially Equivalent
Date received
2003-12-18
Decision date
2004-01-16
Days to decision
29 days
Clearance type
Special
Product code
LSE
Device class
1
Regulation number
866.3235
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
North Miami, FL, US
Third-party review
No
Expedited review
No

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BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062211)Bio-Rad Laboratories, Inc.2006-12-08
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213)Bio-Rad Laboratories, Inc.2006-12-08
LIAISON EA IGG (K060204)DiaSorin, Inc.2006-10-18
EBV VCA-P18 IGG ELISA (K030863)Panbio Limited2003-06-27
EBV EA-D IGG ELISA KIT, MODEL EBG-100 (K021793)Pan Bio Pty. , Ltd.2002-09-27
IMMUNOWELL EA (D) IGG TEST (K010301)Genbio2001-06-11
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM (K992587)Stellar Bio Systems, Inc.1999-12-22

Recalls involving this device

No recalls on record reference this clearance.