Atlas FDA

SERAQUEST CMV IGM

FDA 510(k) clearance K982485 · decided 1999-01-13

Clearance details

K-number
K982485
Device name
SERAQUEST CMV IGM
Applicant
Quest Intl., Inc.
Decision
Substantially Equivalent
Date received
1998-07-17
Decision date
1999-01-13
Days to decision
180 days
Clearance type
Traditional
Product code
LFZ
Device class
2
Regulation number
866.3175
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
North Miami, FL, US
Third-party review
No
Expedited review
No

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IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (K993952)Diagnostic Products Corp.1999-12-16
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K984139)Zeus Scientific, Inc.1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983803)Zeus Scientific, Inc.1998-12-14
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Recalls involving this device

RecordFirmDate
CMV IgM EIA, in vitro diagnostic. recall (Z-0342-2023)Bio-Rad Laboratories, Inc.2022-12-06
SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. recall (Z-0837-2012)Quest International, Inc.2012-01-23