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510(k) K830515

Device
SCOTTS TAP WATER SUBSTITUTE CONCENTRATE
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K830515
Product code
KEQ  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-31
Date received
1983-02-17
Regulation
864.4010
Classification name
Media, Mounting, Water Soluble
Medical specialty
Pathology
Review panel
Pathology
Device class
1
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 KEQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K792702VASPAR SEALANTMeridian Diagnostics, Inc.1980-01-24
K792703LACTO-PHENOL ANALINE BLUE FLUIDMeridian Diagnostics, Inc.1980-01-24
K792709KOH MOUNTING FLUID W/GLYCEROLMeridian Diagnostics, Inc.1980-01-24
K781868DROPPER, CEPTI-SEAL LAVTOPHENOLMarion Laboratories, Inc.1978-11-22
K781869DROPPER, CEPTI-SEAL KOH SOLUTIONMarion Laboratories, Inc.1978-11-22
K781388F.A. MOUNTING MEDIUMFlow Laboratories, Inc.1978-08-21

Legacy Summary#

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FDA Review#

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