Product Code: DPM FDA class 1 21 CFR 862.2260

Columns, Liquid Chromatography

Clinical Chemistry

Columns for Liquid Chromatography are laboratory consumables consisting of packed chromatographic columns used in liquid chromatography instruments to separate analytes in clinical chemistry testing. They are a Class 1 device subject to general controls only, with no premarket notification required. The product code is DPM, regulated under 21 CFR 862.2260, within the Clinical Chemistry specialty. No special regulatory flags apply.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DPM in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DPM
Device Class: FDA class 1
Regulation Number: 862.2260
Medical Specialty: Clinical Chemistry
Review Panel: TX
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 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K952501	TOX PERFECT B TUBES AND REAGENTS	Aug 24, 1995	Substantially Equivalent	Chimera Research & Chemical, Inc.
K895105	HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE	Oct 06, 1989	Substantially Equivalent	Waters Chemical Products
K894141	LIQUID CHROMATOGRAPHY COLUMNS	Aug 21, 1989	Substantially Equivalent	Supelco, Inc.
K891673	ADVANCED PURIFICATION GLASS COLUMN	Apr 26, 1989	Substantially Equivalent	Waters Chemical Products
K884403	LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE	Dec 22, 1988	Substantially Equivalent	Supelco, Inc.
K881868	LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD	Aug 29, 1988	Substantially Equivalent	Supelco, Inc.
K880724	LIQUID CHROMATO. COLUMNS	May 27, 1988	Substantially Equivalent	Supelco, Inc.
K864267	SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)	Jan 09, 1987	Substantially Equivalent	Millipore Corp.
K862541	LIQUID CHROMATOGRAPHY COLUMNS	Jul 29, 1986	Substantially Equivalent	Supelco, Inc.
K861633	LIQUID CHROMATOGRAPHY COLUMNS	May 23, 1986	Substantially Equivalent	Supelco, Inc.
K842909	LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH	Oct 05, 1984	Substantially Equivalent	Supelco, Inc.
K832200	PRP-1 REVERSED PHASE COLUMNS FOR HPLC	Aug 16, 1983	Substantially Equivalent	Hamilton Co.
K813575	LIQUID CHROMATOGRAPHY (HPLC) COLUMNS	Jan 18, 1982	Substantially Equivalent	Supelco, Inc.
K811304	LIQUID CHROMATOGRAPHY COLUMNS	May 27, 1981	Substantially Equivalent	Supelco, Inc.
K802703	LIQUID CHROMATOGRAPHY COLUMNS	Nov 12, 1980	Substantially Equivalent	Supelco, Inc.
K761168	MAX L SYSTEM	Dec 10, 1976	Substantially Equivalent	Brinkman Instruments, Inc.