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510(k) K873594

Device
TIF FECAL TEST
Applicant
DEVETEC, INC.
510(k) number
K873594
Product code
LEA  
Decision
Substantially Equivalent (SESE)
Decision date
1987-09-29
Date received
1987-09-04
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#

Contact
PRICE, PHD
Address
P.O. Box 10275 Bradenton FL US 34282 34282

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
K770592CYTOLOGY FIXATIVESurgipath Medical Industries, Inc.1977-05-20
K761000PAP-TRAY I (CATALOG #C600-1)Lerner Laboratories, Inc.1976-12-06
K761001PAP-TRAY II (CATALOG #C600-2)Lerner Laboratories, Inc.1976-12-06

Legacy Summary#

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FDA Review#

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