Product Code: JQX FDA class 1 21 CFR 862.2700

Nephelometer, For Clinical Use

Clinical Chemistry

The Nephelometer, For Clinical Use is a clinical chemistry instrument that measures the turbidity of a solution by detecting the intensity of light scattered at an angle by particles in suspension, used in quantifying proteins, immunoglobulins, complement components, and other analytes through nephelometric immunoassay methods. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQX and is regulated under 21 CFR 862.2700, within the Clinical Chemistry medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JQX 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: JQX
Device Class: FDA class 1
Regulation Number: 862.2700
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K962294	IMMAGE IMMUNOCHEMISTRY SYSTEM	Aug 21, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K922273	ARRAY(R) 360	Aug 19, 1992	Substantially Equivalent	Beckman Instruments, Inc.
K885263	QMS(TM) - THEOPHYLLINE	Mar 28, 1989	Substantially Equivalent	Seradyn, Inc.
K851253	TDX ANALYZER W/NEPHELOMETRY CAROUSEL	Apr 30, 1985	Substantially Equivalent	Abbott Laboratories
K851234	A-JUST TURBIDITY METER	Apr 29, 1985	Substantially Equivalent	Abbott Laboratories
K801362	ALBUMIN NEPHELOMETRIC ASSAY	Jul 21, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K801089	J.T. BAKER NEPHELOMETER	May 28, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K792045	BIOVATION NEPHELOMETER	Oct 30, 1979	Substantially Equivalent	Biovation, Inc.
K790103	NEPHELOMETER, MIC-2000 LASER	Mar 12, 1979	Substantially Equivalent	Dynatech Corp.
K781554	RAD-291	Oct 11, 1978	Substantially Equivalent	Organon, Inc.
K781644	ANTIBIOTIC NEPHELOMETER	Oct 03, 1978	Substantially Equivalent	Biovation, Inc.
K780251	NEPHELOMETER	Apr 06, 1978	Substantially Equivalent	Kallestad Laboratories, Inc.
K772361	LASER IMMUNONEPHELOMETRIC ANALYZER	Jan 30, 1978	Substantially Equivalent	G.D. Searle and Co.
K771446	TRANSPORTEO MODULE	Aug 10, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories