Hemo-De

FDA 510(k) K822784 · Pmp Industries

Substantially Equivalent

510(k) numberK822784

Submission

Device name
Hemo-De
Applicant
Pmp Industries
Anaheim, CA, US
Received
September 14, 1982
Decision date
November 5, 1982
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
K832011Ameri ClearKEM · Traditional Stephens Scientific08/12/1983SE

Questions and answers

When was Hemo-De cleared by the FDA?

Hemo-De (K822784) received a 510(k) decision of Substantially Equivalent on November 5, 1982, 52 days after the submission was received.

What is the product code of K822784?

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