Product Code: JJN FDA class 1 21 CFR 862.2485

Apparatus, Electrophoresis, For Clinical Use

Clinical Chemistry

This device is an electrophoresis apparatus used in clinical laboratories to separate proteins, nucleic acids, or other charged biomolecules within patient specimens by applying an electric field, enabling identification of abnormal protein patterns associated with conditions such as multiple myeloma or hemoglobinopathies. It is classified as FDA Class 1 and is subject only to general regulatory controls with no premarket notification required. The product code is JJN, regulated under 21 CFR 862.2485, and belongs to the Clinical Chemistry medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JJN 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: JJN
Device Class: FDA class 1
Regulation Number: 862.2485
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 34 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K924021	POWER SUPPLY	Jan 28, 1993	Substantially Equivalent	The Binding Site, Ltd.
K924020	ELECTROPHORESIS TANK	Dec 28, 1992	Substantially Equivalent	The Binding Site, Ltd.
K882344	ELECTR-TRANSBLOTTER	Jan 13, 1989	Substantially Equivalent	The W.E.P. Co.
K881852	REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170	Jul 08, 1988	Substantially Equivalent	Helena Laboratories
K882163	HELENA REP GEL PROCESSOR	Jun 20, 1988	Substantially Equivalent	Helena Laboratories
K873352	RAPID ELECTROPHORESIS SYSTEM (REP)	Sep 08, 1987	Substantially Equivalent	Helena Laboratories
K864436	STAVIP 3000	Mar 16, 1987	Substantially Equivalent	Roseburg SA
K861414	ELECTROPHORESIS WORK CENTER (EWC)	Aug 26, 1986	Substantially Equivalent	Helena Laboratories
K841407	ISOGEL AGAROSE	Jul 16, 1985	Substantially Equivalent	Fmc Corp.
K844710	EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD	Jan 07, 1985	Substantially Equivalent	Logos Scientific, Inc.
K842560	OPTIPHOR-10	Aug 10, 1984	Substantially Equivalent	Gelman Sciences, Inc.
K842485	OPTICLEAR	Aug 10, 1984	Substantially Equivalent	Gelman Sciences, Inc.
K841804	ELVI 70 SAFETY CHAMBER	May 31, 1984	Substantially Equivalent	Logos Scientific, Inc.
K841288	ELVI 18	May 02, 1984	Substantially Equivalent	Logos Scientific, Inc.
K830797	IMMOBILINE SYSTEM LKB 1819	Aug 24, 1983	Substantially Equivalent	Lkb Instruments, Inc.
K823132	SARTOPHOR SYSTEM FOR ELECTROPHORESIS	Nov 27, 1982	Substantially Equivalent	Sartorius Filters, Inc.
K822285	CELLULOSE ACETATE MEMBRANE STRIPS	Sep 21, 1982	Substantially Equivalent	Sartorius Filters, Inc.
K821688	TITAN GEL HIGH RESOLUTION SERUM PROTEIN	Jun 22, 1982	Substantially Equivalent	Helena Laboratories
K821517	TITANAN GEL SERUM PROTEIN ELECTROPHORES	Jun 10, 1982	Substantially Equivalent	Helena Laboratories
K821303	HI-PHORE HIGH RESOLUTION ELECTROPHORES	May 12, 1982	Substantially Equivalent	Gelman Sciences, Inc.
K803281	AUTOMATED ELECTROPHORESIS SYSTEM	Jan 16, 1981	Substantially Equivalent	Helena Laboratories
K802396	GENERAL PROCEDURE AGAROSE FILM	Nov 26, 1980	Substantially Equivalent	Electrophoresis Corp. of America
K802395	SPECIAL PROCEDURE AQAROSE FILM	Nov 26, 1980	Substantially Equivalent	Electrophoresis Corp.
K801893	CORNING 60 VOLT POWER SUPPLY	Sep 16, 1980	Substantially Equivalent	Corning Medical & Scientific
K801378	HIPP BUFFER(NON-BARBITAL), P/N	Jul 14, 1980	Substantially Equivalent	Gelman Sciences, Inc.
K792553	AGAROSE BARBITAL-EDTA BUFFER	Jan 29, 1980	Substantially Equivalent	Electrophoresis Corp. of America
K792547	AGAROSE BARBITAL BUFFER	Jan 29, 1980	Substantially Equivalent	Electrophoresis Corp. of America
K791144	BUFFERIZER	Aug 03, 1979	Substantially Equivalent	Helena Laboratories
K791111	AUTOMATED ELECTROPHORESES MACHINE	Jul 30, 1979	Substantially Equivalent	Gelman Sciences, Inc.
K772176	CYSTIC FIBROSIS TESTING INSTRUMENT	Dec 20, 1977	Substantially Equivalent	Laboratory Equipment Design Co.
K771322	ELECTROPHORESIS POWER SUPPLY TESTER	Oct 18, 1977	Substantially Equivalent	Corning Medical & Scientific
K771323	ELECTROPHORESIS OVEN THERMOMETER	Aug 10, 1977	Substantially Equivalent	Corning Medical & Scientific
K761248	ELECTROPHORESIS ACCESSORY MO. 3526	Dec 21, 1976	Substantially Equivalent	Gilford Instrument Laboratories, Inc.
K760131	AGARO-GEL, PRODUCT # A1266	Jul 20, 1976	Substantially Equivalent	Sigma Chemical Co.