Product Code: IFP FDA class 1 21 CFR 864.4010

Formalin, Neutral Buffered

Pathology

Neutral Buffered Formalin is the most widely used tissue fixative in histopathology, a 10% formaldehyde solution buffered to near-neutral pH to prevent formalin pigment formation, used to preserve biopsy and surgical specimens for routine histological processing and diagnosis. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IFP, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.

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FEI Numbers

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Basic Information

Product Code: IFP
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
K884755	CONSED FECAL CONCENTRATION SYSTEM	Jan 10, 1989	Substantially Equivalent	Donald L. Price, Ph.D.
K872663	DRY-FORM	Aug 06, 1987	Substantially Equivalent	Anatech, Ltd.
K872140	(MSI) PATH-SAVER	Jun 15, 1987	Substantially Equivalent	Medical Specialties, Inc.
K870852	NBF 10% NEUTRAL BUFFERED FORMALIN	Mar 31, 1987	Substantially Equivalent	Anatech, Ltd.
K853497	PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN	Aug 28, 1985	Substantially Equivalent	Surgipath Medical Industries, Inc.
K842982	FORMALIN BUFFERED	Oct 01, 1984	Substantially Equivalent	Reagent Laboratory, Inc.
K842940	CBA FORMALIN	Aug 28, 1984	Substantially Equivalent	Anatech, Ltd.
K842728	BUF-FIX	Aug 03, 1984	Substantially Equivalent	E K Ind., Inc.
K840926	FORMALIN SOLUTION 10% NEUTRAL BUFFER	Mar 12, 1984	Substantially Equivalent	Sigma Chemical Co.
K830583	NEUTRAL BUFFERED FORMALIN 10%	Mar 17, 1983	Substantially Equivalent	Surgipath Medical Industries, Inc.
K830582	MILLONIG'S MODIFIED PHOSPHATE BUFFERED	Mar 17, 1983	Substantially Equivalent	Surgipath Medical Industries, Inc.
K830514	MILLONIGS MODIFIED PHOSPHATE BUFFERED	Mar 08, 1983	Substantially Equivalent	Surgipath Medical Industries, Inc.
K812940	10% NEUTRAL BUFFERED FORMALIN CONCENT	Dec 10, 1981	Substantially Equivalent	Surgipath
K812817	NEUTRAL DUFFERED FORMA-SCENT	Nov 10, 1981	Substantially Equivalent	Meridian Diagnostics, Inc.
K811795	10% NEUTRAL BUFFERED FORMALDEHYDE	Jul 28, 1981	Substantially Equivalent	Richard-Allan Medical Ind., Inc.