Atlas FDA

EBV-EA IFA KIT

FDA 510(k) clearance K895652 · decided 1989-12-18

Clearance details

K-number
K895652
Device name
EBV-EA IFA KIT
Applicant
Organon Teknika Treyburn
Decision
Substantially Equivalent
Date received
1989-09-20
Decision date
1989-12-18
Days to decision
89 days
Clearance type
Traditional
Product code
LSE
Device class
1
Regulation number
866.3235
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Durham, NC, 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
MODIFICATION TO SERAQUEST EB VCA IGG (K033915)Quest Intl., Inc.2004-01-16
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
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Recalls involving this device

No recalls on record reference this clearance.