FDA.reportPublic FDA data

510(k) K883048

Device
ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
Applicant
ALPHA-TEC SYSTEMS, INC.
510(k) number
K883048
Product code
LDZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-08-17
Date received
1988-07-16
Regulation
864.4010
Classification name
Fixative, Alcohol Containing
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAURIE A WILLIAMS
Address
18271 Mcdurmott W., Suite I Irvine CA US 92714 92714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881922CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVESurgipath Medical Industries, Inc.1988-05-25
K881698ATS PVA FIXATIVE SOLUTIONAlpha-Tec Systems, Inc.1988-05-13
K862725SACCOMANNO SPECIMAN SOLUTIONMill-Rose Laboratory1986-08-01
K843428BIOFIXAccra Laboratories, Inc.1984-09-27
K842913WRIGHT STAIN FIXATIVEE K Ind., Inc.1984-09-07
K831061PVA FIXATIVE/FORMALINAmerican Micro Scan1983-06-08
K761138FA TISSUE FIXATIVE & WASH SETZeus Scientific, Inc.1978-01-06

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases