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510(k) K780182

Device
TOBRAMYCIN 125I RIA KIT
Applicant
NEW ENGLAND NUCLEAR
510(k) number
K780182
Product code
DID  
Decision
Substantially Equivalent (SESE)
Decision date
1978-02-13
Date received
1978-02-03
Regulation
862.3900
Classification name
Bacillus Subtilis Microbiology Assay, Tobramycin
Medical specialty
Toxicology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K820773EMIT-ST URINE COCAINE METABOLITE ASSAYSyva Co.1982-04-08
K802038PHENYTOIN REAGENT TEST KITBeckman Instruments, Inc.1980-10-23
K780950BIO-MONITOR TOBRAMYCINMonitor Science Corp.1978-08-14
K780048AMINOGLYCOSIDE TEST SYSTEMNichols Institute Diagnostics1978-01-20

Legacy Summary#

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FDA Review#

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