Product Code: KEM FDA class 1 21 CFR 864.4010

Agent, Clearing

Pathology

Clearing Agent is a chemical reagent used in histological tissue processing to render tissue transparent and miscible with paraffin wax, enabling proper infiltration and embedding prior to sectioning. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KEM, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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Basic Information

Product Code: KEM
Device Class: FDA class 1
Regulation Number: 864.4010
Medical Specialty: Pathology
Review Panel: PA
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K881282	XYLENE	Apr 05, 1988	Substantially Equivalent	Anatech, Ltd.
K874461	HEMO-SOL	Dec 04, 1987	Substantially Equivalent	Chem Pharm, Inc.
K861490	PERMACLEAR SOLUTION CAT. NO. 4950	May 06, 1986	Substantially Equivalent	Helena Laboratories
K855109	CLEARENE, CLEARING AGENT	Jan 07, 1986	Substantially Equivalent	Surgipath Medical Industries, Inc.
K854083	XYLENE SUBSTITUTE MONTANT	Oct 22, 1985	Substantially Equivalent	Lerner Laboratories, Inc.
K853694	XYLENE SUBSTITUTE	Oct 22, 1985	Substantially Equivalent	Lerner Laboratories, Inc.
K842861	PRO-PAR CLEARANT	Aug 21, 1984	Substantially Equivalent	Anatech, Ltd.
K842721	LIMONENE	Aug 03, 1984	Substantially Equivalent	E K Ind., Inc.
K832451	CLEAR-RITE 3	Aug 12, 1983	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K832011	AMERI CLEAR	Aug 12, 1983	Substantially Equivalent	Stephens Scientific
K830627	CLARIFIER-RICHARD-ALLAN	Mar 24, 1983	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K822784	HEMO-DE	Nov 05, 1982	Substantially Equivalent	Pmp Industries
K812847	XYLENE	Oct 29, 1981	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K812846	CLEAR-RITE II	Oct 29, 1981	Substantially Equivalent	Richard-Allan Medical Ind., Inc.
K811798	CLEAR-RITE	Jul 28, 1981	Substantially Equivalent	Richard-Allan Medical Ind., Inc.