510(k) K761001

Device: PAP-TRAY II (CATALOG #C600-2)
Applicant: Lerner Laboratories, Inc.
510(k) number: K761001
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: N

Applicant Contact#

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

FDA Registration Numbers#

1222780
1423537
9710094
3007496191
3006330030
8044093
2013736
3006158025
1221855
3012101172
1950302
3006191977
1114298
3010889828
3023228837
1419341
3012259842
3009034535
1640981
1831638
3011496777
3013500651
3003593973

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)	Device	Applicant	Decision date
K873594	TIF FECAL TEST	Devetec, Inc.	1987-09-29
K770592	CYTOLOGY FIXATIVE	Surgipath Medical Industries, Inc.	1977-05-20
K761000	PAP-TRAY I (CATALOG #C600-1)	Lerner Laboratories, Inc.	1976-12-06