Pap-Tray II (Catalog #C600-2)

FDA 510(k) K761001 · Lerner Laboratories, Inc.

Substantially Equivalent

510(k) numberK761001

Submission

Device name
Pap-Tray II (Catalog #C600-2)
Applicant
Lerner Laboratories, Inc.
Mchenry, IL, US
Received
November 8, 1976
Decision date
December 6, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LEA – Preservative, Cytological
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code LEA

510(k)DeviceApplicantDecision
K873594Tif Fecal TestLEA · Traditional Devetec, Inc.09/29/1987SE
K770592Cytology FixativeLEA · Traditional Surgipath Medical Industries, Inc.05/20/1977SE
K761000Pap-Tray I (Catalog #C600-1)LEA · Traditional Lerner Laboratories, Inc.12/06/1976SE

More from Lerner Laboratories, Inc.

510(k)DeviceDecision
K854083Xylene Substitute MontantKEM · Traditional 10/22/1985SE
K853694Xylene SubstituteKEM · Traditional 10/22/1985SE
K821443FormicalKDX · Traditional 06/02/1982SE
K761000Pap-Tray I (Catalog #C600-1)LEA · Traditional 12/06/1976SE

Questions and answers

When was Pap-Tray II (Catalog #C600-2) cleared by the FDA?

Pap-Tray II (Catalog #C600-2) (K761001) received a 510(k) decision of Substantially Equivalent on December 6, 1976, 28 days after the submission was received.

What is the product code of K761001?

The FDA product code is LEA – Preservative, Cytological, a Class I (low risk) device regulated under 21 CFR 864.4010.