Product Code: DFT FDA class 2 21 CFR 866.5550

Igm, Antigen, Antiserum, Control

Immunology

The IgM Antigen, Antiserum, and Control is an immunological reagent used to detect and quantify IgM immunoglobulins, the first antibody class produced in response to infection, in biological specimens. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5550 within the Immunology specialty. The device qualifies for third-party 510(k) review by an FDA-accredited organization.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DFT
Device Class: FDA class 2
Regulation Number: 866.5550
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

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 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K983132	IGM	Nov 04, 1998	Substantially Equivalent	Abbott Laboratories
K962201	QUANTEX IGM	Sep 25, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K955797	IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR	Apr 05, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K945522	I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS	Dec 12, 1994	Substantially Equivalent	Beckman-Diagnostic Systems Group
K901453	QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD	Apr 12, 1990	Substantially Equivalent	Isolab, Inc.
K894417	RAICHEM(TM) SPIA(TM) IGM REAGENTS	Aug 02, 1989	Substantially Equivalent	Reagents Applications, Inc.
K884147	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M	Oct 27, 1988	Substantially Equivalent	Orion Diagnostica, Inc.
K880828	WAKO(TM) IGM-HA DIRECT	Mar 25, 1988	Substantially Equivalent	Wako Chemicals USA, Inc.
K873871	IMMUNOGLOBULINS M	Oct 13, 1987	Substantially Equivalent	Unipath , Ltd.
K872237	KALLESTAD QM300 IGM ANTIBODY PACK	Jul 09, 1987	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K871498	TITAN GEL IMMUNOFIX CONTROLS	Apr 29, 1987	Substantially Equivalent	Helena Laboratories
K862762	TINA-QUANT(R) IGM	Sep 08, 1986	Substantially Equivalent	Boehringer Mannheim Corp.
K855010	QUANTIMETRIC PLUS IGM REAGENT KIT	Feb 28, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K853469	GILFORD IMMUNOGLOBULIN M REAGENT	Sep 16, 1985	Substantially Equivalent	Gilford
K842327	AMER. HISTO-ID SYS PRIMARY IGM S7920-31	Aug 02, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K841814	OPTIMATE IGM TEST	Jun 22, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K832265	FITC GOAT ANTI-HUMAN IGM H CHAIN	Oct 31, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K832259	GOAT ANTI-HUMAN IGM H CHAIN	Oct 28, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K831608	FIAX IGM TEST KIT	Jun 22, 1983	Substantially Equivalent	Intl. Diagnostic Technology
K831103	TIA-IGM REAGENT & CALIBRATOR SETS	Apr 27, 1983	Substantially Equivalent	Worthington Diagnostic Systems
K830606	QUIK-SEP IGM ISOLATION SYSTEM	Mar 24, 1983	Substantially Equivalent	Isolab, Inc.
K812632	ACA IMMUNOGLOBIN M TEST PACK	Sep 29, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K811124	AIM SYSTEM (FOR IGM)	May 08, 1981	Substantially Equivalent	Icl Scientific
K803251	AIP SYSTEM-METHOD FOR IGM	Jan 26, 1981	Substantially Equivalent	Icl Scientific
K802177	GOAT ANTI-HUMAN IGM	Oct 31, 1980	Substantially Equivalent	Protos Laboratories
K801282	J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA	Jun 30, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K800167	IMMUNOGLOBULIN M REAGENT SYSTEM	Feb 05, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K791402	LANCER L-INA ANTI-IGM	Oct 17, 1979	Substantially Equivalent	Sherwood Medical Co.
K772254	IMMUNOGLOBULIN M NEPHEL. ASSAY	Dec 22, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K770963	GOAT ANTISERUM IGM NEPHELOMHTRIC	Jun 24, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K760917	LAS-R HUMAN HAPTOGLOBIN TEST	Dec 30, 1976	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K760673	RAPI/TEX-LGM KIT	Dec 19, 1976	Substantially Equivalent	Hoechst-Roussel Pharmaceuticals, Inc.
K760147	SERUM, IGM ANTI-HUMAN ACID	Jul 20, 1976	Substantially Equivalent	Oxford Laboratories, Inc.