Atlas FDA

CMV ELISA TEST SYSTEM

FDA 510(k) clearance K924096 · decided 1993-04-02

Clearance details

K-number
K924096
Device name
CMV ELISA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
Decision
Substantially Equivalent
Date received
1992-08-13
Decision date
1993-04-02
Days to decision
232 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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Recalls involving this device

RecordFirmDate
Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 6 recall (Z-1127-03)Meridian Bioscience 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