Atlas FDA

JJN

34 FDA 510(k) clearances · Product code

46 daysmedian time to decision
163 days90th percentile
34clearances measured

FDA profile

Official device name
Apparatus, Electrophoresis, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2485
Medical specialty
Clinical Chemistry
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RecordFirmDate
POWER SUPPLY (K924021)The Binding Site, Ltd.1993-01-28
ELECTROPHORESIS TANK (K924020)The Binding Site, Ltd.1992-12-28
ELECTR-TRANSBLOTTER (K882344)The W.E.P. Co.1989-01-13
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (K881852)Helena Laboratories1988-07-08
HELENA REP GEL PROCESSOR (K882163)Helena Laboratories1988-06-20
RAPID ELECTROPHORESIS SYSTEM (REP) (K873352)Helena Laboratories1987-09-08
STAVIP 3000 (K864436)Roseburg SA1987-03-16
ELECTROPHORESIS WORK CENTER (EWC) (K861414)Helena Laboratories1986-08-26
ISOGEL AGAROSE (K841407)Fmc Corp.1985-07-16
EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (K844710)Logos Scientific, Inc.1985-01-07
OPTIPHOR-10 (K842560)Gelman Sciences, Inc.1984-08-10
OPTICLEAR (K842485)Gelman Sciences, Inc.1984-08-10
ELVI 70 SAFETY CHAMBER (K841804)Logos Scientific, Inc.1984-05-31
ELVI 18 (K841288)Logos Scientific, Inc.1984-05-02
IMMOBILINE SYSTEM LKB 1819 (K830797)Lkb Instruments, Inc.1983-08-24
SARTOPHOR SYSTEM FOR ELECTROPHORESIS (K823132)Sartorius Filters, Inc.1982-11-27
CELLULOSE ACETATE MEMBRANE STRIPS (K822285)Sartorius Filters, Inc.1982-09-21
TITAN GEL HIGH RESOLUTION SERUM PROTEIN (K821688)Helena Laboratories1982-06-22
TITANAN GEL SERUM PROTEIN ELECTROPHORES (K821517)Helena Laboratories1982-06-10
HI-PHORE HIGH RESOLUTION ELECTROPHORES (K821303)Gelman Sciences, Inc.1982-05-12
AUTOMATED ELECTROPHORESIS SYSTEM (K803281)Helena Laboratories1981-01-16
SPECIAL PROCEDURE AQAROSE FILM (K802395)Electrophoresis Corp.1980-11-26
GENERAL PROCEDURE AGAROSE FILM (K802396)Electrophoresis Corp. of America1980-11-26
CORNING 60 VOLT POWER SUPPLY (K801893)Corning Medical & Scientific1980-09-16
HIPP BUFFER(NON-BARBITAL), P/N (K801378)Gelman Sciences, Inc.1980-07-14
AGAROSE BARBITAL-EDTA BUFFER (K792553)Electrophoresis Corp. of America1980-01-29
AGAROSE BARBITAL BUFFER (K792547)Electrophoresis Corp. of America1980-01-29
BUFFERIZER (K791144)Helena Laboratories1979-08-03
AUTOMATED ELECTROPHORESES MACHINE (K791111)Gelman Sciences, Inc.1979-07-30
CYSTIC FIBROSIS TESTING INSTRUMENT (K772176)Laboratory Equipment Design Co.1977-12-20
ELECTROPHORESIS POWER SUPPLY TESTER (K771322)Corning Medical & Scientific1977-10-18
ELECTROPHORESIS OVEN THERMOMETER (K771323)Corning Medical & Scientific1977-08-10
ELECTROPHORESIS ACCESSORY MO. 3526 (K761248)Gilford Instrument Laboratories, Inc.1976-12-21
AGARO-GEL, PRODUCT # A1266 (K760131)Sigma Chemical Co.1976-07-20

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