Atlas FDA

CMV ELISA TEST SYSTEM

FDA 510(k) clearance K891081 · decided 1989-06-02

Clearance details

K-number
K891081
Device name
CMV ELISA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
Decision
Substantially Equivalent
Date received
1989-03-01
Decision date
1989-06-02
Days to decision
93 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

+ Add to Predicate Builder ◉ Watch Zeus Scientific

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (K181213)Siemens Healthcare Diagnostics, Inc.2018-07-30
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

Recalls involving this device

RecordFirmDate
Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Sci recall (Z-1095-03)Zeus Scientific Inc2003-08-12

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