Product Code: KTQ FDA class 1 21 CFR 866.4100

Reagent, Complement

Immunology

The Complement Reagent is an in vitro diagnostic reagent used in complement fixation assays and related serological tests to detect the presence of specific antibodies or antigens in patient samples, with broad applications in infectious disease and autoimmune testing. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and exempt from premarket notification. The product code is KTQ, regulated under 21 CFR 866.4100, in the Immunology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code KTQ 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: KTQ
Device Class: FDA class 1
Regulation Number: 866.4100
Medical Specialty: Immunology
Review Panel: IM
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 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K890417	SPQ(TM) ANTIBODY REAGENT SET II FOR C3	Feb 17, 1989	Substantially Equivalent	Atlantic Antibodies
K812522	RABBIT COMPLEMENT	Sep 23, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812370	GUINEA PIG COMPLEMENT REGULAR	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K812369	GUINEA PIG COMPLEMENT VIRUS ANTIBODY	Sep 08, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K791117	RABBIT COMPLEMENT	Aug 03, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K790380	LOW-TOX-H RABBIT COMPLEMENT	Mar 21, 1979	Substantially Equivalent	Cederlane Labs , Ltd.