FDA.reportPublic FDA data

510(k) K761000

Device
PAP-TRAY I (CATALOG #C600-1)
Applicant
LERNER LABORATORIES, INC.
510(k) number
K761000
Product code
LEA  
Decision
Substantially Equivalent (SESE)
Decision date
1976-12-06
Date received
1976-11-08
Regulation
864.4010
Classification name
Preservative, Cytological
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 LEA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873594TIF FECAL TESTDevetec, Inc.1987-09-29
K770592CYTOLOGY FIXATIVESurgipath Medical Industries, Inc.1977-05-20
K761001PAP-TRAY II (CATALOG #C600-2)Lerner Laboratories, Inc.1976-12-06

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