Atlas FDA

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

FDA 510(k) clearance K181213 · decided 2018-07-30

Clearance details

K-number
K181213
Device name
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2018-05-07
Decision date
2018-07-30
Days to decision
84 days
Clearance type
Traditional
Product code
LFZ
Device class
2
Regulation number
866.3175
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Architect CMV IgG (K220949)Abbott Laboratories2022-10-27
Elecsys CMV IgG (K220911)Roche Diagnostics2022-10-12
Elecsys CMV IgM (K163569)Roche Diagnostics2017-03-17
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set (K162969)DiaSorin, Inc.2017-01-06
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM (K142133)Roche Diagnostics2014-10-24
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (K131605)Roche Diagnostics2014-02-28
DIASORIN LIAISON CMV IGM/IGG (K040290)Diasorin S.P.A2005-06-01
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 (K993952)Diagnostic Products Corp.1999-12-16
SERAQUEST CMV IGM (K982485)Quest Intl., Inc.1999-01-13
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
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY (K982027)DiaSorin, Inc.1998-11-25

Recalls involving this device

No recalls on record reference this clearance.

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