Ameri Clear

FDA 510(k) K832011 · Stephens Scientific

Substantially Equivalent

510(k) numberK832011

Submission

Device name
Ameri Clear
Applicant
Stephens Scientific
Mchenry, IL, US
Received
June 23, 1983
Decision date
August 12, 1983
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
K853694Xylene SubstituteKEM · 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
K830627Clarifier-Richard-AllanKEM · Traditional Richard-Allan Medical Ind., Inc.03/24/1983SE

More from Richard-Allan Medical Ind., Inc.

510(k)DeviceDecision
K893772Tissue Embedding MediumKEO · Traditional 06/22/1989SE
K881359Decalcifying Solution IIKOX · Traditional 04/19/1988SE
K872625Decalcifying SolutionKDX · Traditional 08/06/1987SE

Questions and answers

When was Ameri Clear cleared by the FDA?

Ameri Clear (K832011) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 50 days after the submission was received.

What is the product code of K832011?

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