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510(k) K841556

Device
HEART - AID ALS, 95
Applicant
CARDIAC RESUCITATOR CORP.
510(k) number
K841556
Product code
LDO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-19
Date received
1984-04-16
Regulation
862.3900
Classification name
Enzymatic Radiochemical Assay, Tobramycin
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 LDO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K043384VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.2005-02-07
K832055EMIT ASSAY AND TOBRAMYCINSyva Co.1983-08-08

Legacy Summary#

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FDA Review#

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