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Helena Laboratories

280 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
TITAN GE/IEPLATE (K831603)Helena Laboratories1983-07-07
HELENA BIOSTRIP A (K830978)Helena Laboratories1983-05-13
HELENA BIOSTRIP PH (K830979)Helena Laboratories1983-05-05
HELENA BIOSTRIP K (K830976)Helena Laboratories1983-05-04
HELENA BIOSTRIP P (K830977)Helena Laboratories1983-04-28
TITAN GEL LDH ISO-ENZYME CONTROL (K830872)Helena Laboratories1983-04-12
NEGATIVE URINE CONTROL (K830834)Helena Laboratories1983-04-12
ACTIVAT-PARTIAL THROMBO-PLASTIN (K830320)Helena Laboratories1983-04-05
LIQUID THROMBOPLASTIN REAGENT (K830331)Helena Laboratories1983-04-05
TITAN IMMUNO-FIX (K830594)Helena Laboratories1983-03-24
GLYCO HB QUIK COLUMN PROCEDURE (K823869)Helena Laboratories1983-02-01
BETA THALQUIK COLUMN #5341 (K823870)Helena Laboratories1983-02-01
FACTOR VIII RELATED ANTIGEN ROCKET EID (K823267)Helena Laboratories1982-12-28
TITAN GEL LDH ISOENZYME KIT (K821983)Helena Laboratories1982-12-22
TITAN GEL CPK ISOENZYME SYSTEM (K822124)Helena Laboratories1982-11-01
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO (K822050)Helena Laboratories1982-08-27
TITAN GEL SERUM CONTROL (K821982)Helena Laboratories1982-08-16
ISOPROPANOL HEMOGLOBIN STABILITY TEST (K822123)Helena Laboratories1982-08-05
IMMUNO DIAGNOSTICS ASSAY (K822026)Helena Laboratories1982-08-03
TITAN GEL CPK/LDH ISOENZYME CONTROL (K821981)Helena Laboratories1982-07-22
TITAN GEL HIGH RESOLUTION SERUM PROTEIN (K821688)Helena Laboratories1982-06-22
TITANAN GEL SERUM PROTEIN ELECTROPHORES (K821517)Helena Laboratories1982-06-10
FETAL-TEK CONTROL (IMMATURE/BORDERLINE) (K820772)Helena Laboratories1982-05-12
BIOSTRIP G (K820594)Helena Laboratories1982-05-05
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (K820787)Helena Laboratories1982-04-08
HELENA HEMOGLOBIN DETECT COLUMN SYS (K820573)Helena Laboratories1982-04-01
AVES WRIGHT STAIN (K820437)Helena Laboratories1982-03-26
FETAL-TEK CONTROL MATURE (K820319)Helena Laboratories1982-03-25
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (K813395)Helena Laboratories1981-12-31
HELENA COLOSCREEN METHOD (K812428)Helena Laboratories1981-10-23
HELENA HBF QUIPLATE CONTROL (K812226)Helena Laboratories1981-09-01
HELENA SICKLE-THAL QUIK COLUMN METHOD (K812077)Helena Laboratories1981-08-18
HELENA VMA-SMC CONTROL (K811912)Helena Laboratories1981-07-23
HELENA PLASMINOGEN QUIPLATE PROCEDURE (K811777)Helena Laboratories1981-07-02
HELENA FETAL-TEK 200 MARKER (K811695)Helena Laboratories1981-07-01
HELENA FETAL-TEK 200 METHOD (K811588)Helena Laboratories1981-06-25
HELENA VMA-SMC COLUMN METHOD (K810992)Helena Laboratories1981-04-29
HELENA HEMOGLOBIN F CONTROLS (K810475)Helena Laboratories1981-03-26
AUTOMATED ELECTROPHORESIS SYSTEM (K803281)Helena Laboratories1981-01-16
HELENA HBA2 QUIK COLUMN METHOD (K803108)Helena Laboratories1981-01-09
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. (K803016)Helena Laboratories1980-12-30
HEMESPEC II (K803015)Helena Laboratories1980-12-30
HELENA AT-III QUIPLATE PROCEDURE (K802912)Helena Laboratories1980-12-22
AB-TROL COAGULATION CONTROL (K802232)Helena Laboratories1980-11-12
KEMTROL SERUM CONTROL-NORMAL (K802108)Helena Laboratories1980-10-10
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN (K802233)Helena Laboratories1980-10-10
KEMTROL SERUM CONTROL ABNORMAL (K802109)Helena Laboratories1980-10-10
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH (K800857)Helena Laboratories1980-09-26
HEP-TROL (K801932)Helena Laboratories1980-09-09
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE (K801318)Helena Laboratories1980-07-14
HEMESPEC CHECK SET (K800852)Helena Laboratories1980-05-02
HELENA COLOCHECK (K800433)Helena Laboratories1980-05-02
A,SA2 LYOPHILIZED HEMO CONTROL (K800853)Helena Laboratories1980-04-29
A,FDA2 LYOPHILIZED HEMO CONTROL (K800856)Helena Laboratories1980-04-29
A,A2 LYOPHILIZED HEMO CONTROL (K800854)Helena Laboratories1980-04-29
A,FSC LYOPHILIZED HEMO CONTROL (K800855)Helena Laboratories1980-04-29
HELENA RISTOCETIN (K800432)Helena Laboratories1980-03-25
HELENA FACTOR XII DEFICIENT (K792656)Helena Laboratories1980-01-24
HELENA COLOSCREEN (K792655)Helena Laboratories1980-01-24
HELENA FACTOR XI DEFICIENT SUBSTRATE (K792476)Helena Laboratories1979-12-31
HELENA FACTOR V DEFICIENT SUBSTRATE (K792507)Helena Laboratories1979-12-31
HELENA FACTOR VII DEFICIENT SUB. PLASMA (K792511)Helena Laboratories1979-12-31
HELENA FACTOR IX DEFICIENT SUBSTRATE (K792475)Helena Laboratories1979-12-31
HELENA FACTOR X DEFICIENT SUBSTRATE (K792508)Helena Laboratories1979-12-31
HELENA FACTOR II DEFICIENT SUB. PLASMA (K792336)Helena Laboratories1979-12-27
NORM-TROL (K792310)Helena Laboratories1979-12-04
HELENA FACTOR VIII DEFICIENT SUB. PLASMA (K792335)Helena Laboratories1979-12-04
LYOPHILIZED HDL CHOLESTEROL CONTROLS (K792025)Helena Laboratories1979-10-30
LIPOTROL (K792024)Helena Laboratories1979-10-30
SPECTRO-SUR SET (K791315)Helena Laboratories1979-08-16
BUFFERIZER (K791144)Helena Laboratories1979-08-03
LYOPHILIZED G-HB QUIK COLUMN CONTROL (K791135)Helena Laboratories1979-06-28
FETAL MATURITY TEST PROCEDURE (K790798)Helena Laboratories1979-06-05
COAGULATION ARP (K790826)Helena Laboratories1979-05-31
HELENA QUIPLATE SYSTEM (K790646)Helena Laboratories1979-05-23
QUIK COLUMN METHODOLOGY (K790583)Helena Laboratories1979-04-23
G-HB QUIK COLUMN CONTROL (K790046)Helena Laboratories1979-01-26
HEMESPEC (K782035)Helena Laboratories1979-01-17
HBF-QUIPLATE METHODOLOGY (K780807)Helena Laboratories1978-06-02
HDL CHOLESTEROL METHOD (K780256)Helena Laboratories1978-03-28
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