Atlas FDA

ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM

FDA 510(k) clearance K981021 · decided 1998-06-02

Clearance details

K-number
K981021
Device name
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
Applicant
Zeus Scientific, Inc.
Decision
Substantially Equivalent
Date received
1998-03-19
Decision date
1998-06-02
Days to decision
75 days
Clearance type
Traditional
Product code
MID
Device class
2
Regulation number
866.5660
Medical specialty
Immunology
Advisory committee
Immunology
Location
Branchburg, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a tes recall (Z-0214-05)Zeus Scientific Inc2004-11-20

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