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510(k) K780949

Device
BIO-MONITOR AMIKACIN
Applicant
MONITOR SCIENCE CORP.
510(k) number
K780949
Product code
KLP  
Decision
Substantially Equivalent (SESE)
Decision date
1978-08-14
Date received
1978-06-09
Regulation
862.3035
Classification name
Amikacin Serum Assay
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KLP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K032279ONLINE TDM AMIKARoche Diagnostics Corp.2003-10-10
K873426EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645Em Diagnostic Systems, Inc.1987-10-29
K790899BACTECBd Becton Dickinson Vacutainer Systems Preanalytic1979-05-23

Legacy Summary#

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FDA Review#

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