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510(k) K934003

Device
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
Applicant
BAXTER DIAGNOSTICS, INC.
510(k) number
K934003
Product code
DKA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-22
Date received
1993-08-17
Regulation
862.3320
Classification name
Antiserum, Digoxin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RONALD H LENTSCH
Address
Scientific Products Div. 1430 Waukegan Rd. Mcgaw Park IL US 60085 60085

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K780498CBR-DIGOXIN ANTISERUMClinical Bioresearch1978-04-05
K780316RABBIT ANTIBODY TO DIGOXINPcl-Ria, Inc.1978-03-17

Legacy Summary#

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FDA Review#

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