Atlas FDA

Elecsys CMV IgM

FDA 510(k) clearance K163569 · decided 2017-03-17

Clearance details

K-number
K163569
Device name
Elecsys CMV IgM
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2016-12-19
Decision date
2017-03-17
Days to decision
88 days
Clearance type
Traditional
Product code
LFZ
Device class
2
Regulation number
866.3175
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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RecordFirmDate
Architect CMV IgG (K220949)Abbott Laboratories2022-10-27
Elecsys CMV IgG (K220911)Roche Diagnostics2022-10-12
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213)Siemens Healthcare Diagnostics, Inc.2018-07-30
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.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01