Hemo-Sol

FDA 510(k) K874461 · Chem Pharm, Inc.

Substantially Equivalent

510(k) numberK874461

Submission

Device name
Hemo-Sol
Applicant
Chem Pharm, Inc.
Dallas, TX, US
Received
October 29, 1987
Decision date
December 4, 1987
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
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
K832011Ameri ClearKEM · Traditional Stephens Scientific08/12/1983SE
K830627Clarifier-Richard-AllanKEM · Traditional Richard-Allan Medical Ind., Inc.03/24/1983SE

Questions and answers

When was Hemo-Sol cleared by the FDA?

Hemo-Sol (K874461) received a 510(k) decision of Substantially Equivalent on December 4, 1987, 36 days after the submission was received.

What is the product code of K874461?

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