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510(k) K800364

Device
ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202
Applicant
HOFFREL INSTRUMENTS, INC.
510(k) number
K800364
Product code
DKX  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-12
Date received
1980-02-20
Regulation
862.3150
Classification name
Thin Layer Chromatography, Barbiturate
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 DKX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016Icn Biomedicals, Inc.2003-06-13

Legacy Summary#

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FDA Review#

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