Xylene Substitute

FDA 510(k) K853694 · Lerner Laboratories, Inc.

Substantially Equivalent

510(k) numberK853694

Submission

Device name
Xylene Substitute
Applicant
Lerner Laboratories, Inc.
New Haven, CT, US
Received
September 4, 1985
Decision date
October 22, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KEM – Agent, Clearing
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code KEM

510(k)DeviceApplicantDecision
K881282XyleneKEM · Traditional Anatech, Ltd.04/05/1988SE
K874461Hemo-SolKEM · Traditional Chem Pharm, Inc.12/04/1987SE
K861490Permaclear Solution Cat. No. 4950KEM · Traditional Helena Laboratories05/06/1986SE
K855109Clearene, Clearing AgentKEM · Traditional Surgipath Medical Industries, Inc.01/07/1986SE
K854083Xylene Substitute MontantKEM · Traditional Lerner Laboratories, Inc.10/22/1985SE
K842861Pro-Par ClearantKEM · Traditional Anatech, Ltd.08/21/1984SE
K842721LimoneneKEM · Traditional E K Ind., Inc.08/03/1984SE
K832451Clear-Rite 3KEM · Traditional Richard-Allan Medical Ind., Inc.08/12/1983SE
K832011Ameri ClearKEM · Traditional Stephens Scientific08/12/1983SE
K830627Clarifier-Richard-AllanKEM · Traditional Richard-Allan Medical Ind., Inc.03/24/1983SE

More from Richard-Allan Medical Ind., Inc.

510(k)DeviceDecision
K854083Xylene Substitute MontantKEM · Traditional 10/22/1985SE
K821443FormicalKDX · Traditional 06/02/1982SE
K761001Pap-Tray II (Catalog #C600-2)LEA · Traditional 12/06/1976SE
K761000Pap-Tray I (Catalog #C600-1)LEA · Traditional 12/06/1976SE

Questions and answers

When was Xylene Substitute cleared by the FDA?

Xylene Substitute (K853694) received a 510(k) decision of Substantially Equivalent on October 22, 1985, 48 days after the submission was received.

What is the product code of K853694?

The FDA product code is KEM – Agent, Clearing, a Class I (low risk) device regulated under 21 CFR 864.4010.