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THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

FDA 510(k) clearance K983803 · decided 1998-12-14

Clearance details

K-number
K983803
Device name
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
Applicant
Zeus Scientific, Inc.
Decision
Substantially Equivalent
Date received
1998-10-28
Decision date
1998-12-14
Days to decision
47 days
Clearance type
Traditional
Product code
LFZ
Device class
2
Regulation number
866.3175
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Raritan, NJ, 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
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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
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
ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042)Zeus Scientific, Inc.2017-09-19
ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045)Zeus Scientific, Inc.2017-09-19
FLUORO-CEP (R) PROGESTERONE (P900025/S001)Zeus Scientific, Inc.1992-04-21
FLUORO-CEP (R) PROGESTERONE (P900025/S002)Zeus Scientific, Inc.1992-04-17
FLUORO-CEP (R) PROGESTERONE (P900025)Zeus Scientific, Inc.1990-09-26