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Helena Laboratories

280 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
HELENA THROMBOPLASTIN REAGENT WITH DILUENT (K905807)Helena Laboratories1991-04-16
REP SPE PLUS (ACID BLUE) SYSTEM (K911468)Helena Laboratories1991-04-16
HELENA THROMBOPLASTIN REAGENT, MODIFICATION (K905857)Helena Laboratories1991-02-27
AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 (K905673)Helena Laboratories1991-02-11
FREE PROTEIN S REAGENT CAT. NO. 5363 (K904247)Helena Laboratories1991-01-18
TITAN GEL (K905149)Helena Laboratories1991-01-03
REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (K904035)Helena Laboratories1990-11-09
CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE (K902083)Helena Laboratories1990-06-15
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 (K901414)Helena Laboratories1990-06-15
REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) (K901463)Helena Laboratories1990-06-12
REP(R) IMMUNOFIX (K901805)Helena Laboratories1990-06-06
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 (K901380)Helena Laboratories1990-05-25
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K901143)Helena Laboratories1990-05-23
TIP TOP(R) DISPENSER CAPS (K896670)Helena Laboratories1990-03-23
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359 (K896174)Helena Laboratories1990-03-15
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 (K900422)Helena Laboratories1990-02-27
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 (K900251)Helena Laboratories1990-02-26
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (K896170)Helena Laboratories1990-02-16
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 (K897136)Helena Laboratories1990-02-05
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) (K900017)Helena Laboratories1990-01-29
ROCKET REFERENCE PLASMA, CAT NO. 5188 (K900019)Helena Laboratories1990-01-25
REP(TM) SPE PLUS-30 PROCEDURES (K896572)Helena Laboratories1990-01-11
PROTOFLUOR Z (K893038)Helena Laboratories1989-11-17
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 (K895528)Helena Laboratories1989-10-25
REP TM SPE (PONCEAU S) PROCEDURES (K894585)Helena Laboratories1989-09-13
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (K894366)Helena Laboratories1989-08-31
REP(TM) CK-2 STAT KIT, CAT. NO. 3074 (K893007)Helena Laboratories1989-07-20
REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 (K893224)Helena Laboratories1989-06-20
REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (K892818)Helena Laboratories1989-06-20
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 (K893211)Helena Laboratories1989-06-19
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 (K893223)Helena Laboratories1989-06-09
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 (K892424)Helena Laboratories1989-06-09
HELENA THROMBOPLASTIN REAGENT (K892050)Helena Laboratories1989-06-07
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (K891683)Helena Laboratories1989-04-12
TITAN GEL IFE TRIVALENT ANTISERUM (K891188)Helena Laboratories1989-03-22
MID-LEVEL IGG KIT CAT. NO. 9315 (K891299)Helena Laboratories1989-03-22
TITAN GEL ALKALINE PHOSPHATASE (HR) (K885341)Helena Laboratories1989-02-23
LABILE LYSING REAGENT (K884315)Helena Laboratories1988-12-27
PUMPETTE(TM) (K884111)Helena Laboratories1988-12-14
REP GLYCO SYSTEM (K881863)Helena Laboratories1988-09-30
HELENA COLOCARE (K882799)Helena Laboratories1988-09-30
OWREN'S VERONAL BUFFER (K883484)Helena Laboratories1988-08-25
REP HDL ELECTROPHORESIS METHOD (K882368)Helena Laboratories1988-08-08
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (K881852)Helena Laboratories1988-07-08
HELENA REP GEL PROCESSOR (K882163)Helena Laboratories1988-06-20
REP LIPO KIT CAT. NO 3180 (K881809)Helena Laboratories1988-06-01
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM (K880698)Helena Laboratories1988-05-06
HBF DILUENT (K880653)Helena Laboratories1988-04-21
FACTOR VIII REFERENCE PLASMA (K880292)Helena Laboratories1988-02-19
TITAN GEL REP LDH-30 HV (K874142)Helena Laboratories1987-11-24
TITAN GEL REP LDH-6 HV (K874145)Helena Laboratories1987-11-24
TITAN GEL REP LDH-12 HV (K874143)Helena Laboratories1987-11-23
TITAN GEL REP CPK-6 HV (K874144)Helena Laboratories1987-11-23
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA (K873384)Helena Laboratories1987-11-20
TITAN GEL REP CPK-12 HV (K874146)Helena Laboratories1987-11-05
TITAN GEL REP CPK/LDH ISOENZYME CONTROL (K874141)Helena Laboratories1987-11-04
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. (K874140)Helena Laboratories1987-11-03
TITAN GEL REP CPK-30 HV (K874139)Helena Laboratories1987-11-03
TITAN GEL CPK REP SYSTEM (K873399)Helena Laboratories1987-10-20
TITAN GEL LDH REP SYSTEM (K873386)Helena Laboratories1987-10-20
TITAN GEL HDL CHOLESTEROL KIT (K873547)Helena Laboratories1987-10-02
RAPID ELECTROPHORESIS SYSTEM (REP) (K873352)Helena Laboratories1987-09-08
PROTOFLUOR Z (K871499)Helena Laboratories1987-08-25
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (K872834)Helena Laboratories1987-08-12
CHROM-TROL (K872377)Helena Laboratories1987-07-09
Q.I.C. BLEEDING TIME DEVICE (K871318)Helena Laboratories1987-06-10
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT (K870890)Helena Laboratories1987-06-01
TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 (K870958)Helena Laboratories1987-04-29
TITAN GEL IMMUNOFIX CONTROLS (K871498)Helena Laboratories1987-04-29
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM (K871319)Helena Laboratories1987-04-22
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS (K871352)Helena Laboratories1987-04-22
ELECTROPHORESIS DATA CENTER (EDC) (K860645)Helena Laboratories1986-12-17
ELECTROPHORESIS WORK CENTER (EWC) (K861414)Helena Laboratories1986-08-26
SURESPOT (K862701)Helena Laboratories1986-08-19
HEMAFLUOR REAGENT KIT (K860309)Helena Laboratories1986-07-14
CK/LD BUFFER (CAT. NO. 5808) (K861750)Helena Laboratories1986-05-29
PERMACLEAR SOLUTION CAT. NO. 4950 (K861490)Helena Laboratories1986-05-06
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE (K852392)Helena Laboratories1985-10-22
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (K852391)Helena Laboratories1985-10-01
MONITOR IV PLUS (K851669)Helena Laboratories1985-07-23
COLOSCREEN SELF-TEST (K843352)Helena Laboratories1984-12-05
TITAN GEL ISO DOT LDH KIT (K842669)Helena Laboratories1984-11-09
GLYCO-TEK AFFINITY COLUMN (K842689)Helena Laboratories1984-10-15
TITAN GEL ISO DOT CPK PROCEDURE (K842755)Helena Laboratories1984-09-28
HELENA COLOSCREEN SELF-TEST (K840903)Helena Laboratories1984-08-10
FIBRINOGEN ASSAY KIT (K841020)Helena Laboratories1984-05-02
BIOSURE (K840848)Helena Laboratories1984-05-01
RISTOCETIN COFACTOR ASSAY (K840329)Helena Laboratories1984-04-05
TITAN GEL LIPOPROTEIN ELECTROPHORESIS (K833611)Helena Laboratories1984-03-15
TITAN GEL SILVER STAIN SYSTEM (K833855)Helena Laboratories1984-02-27
AUTO AIC ANALYZER SYSTEM (K833772)Helena Laboratories1984-01-18
HELENA BIO STRIP OB (K834456)Helena Laboratories1984-01-13
TITANGEL HIGH RESOLUTION CONTROL (K833639)Helena Laboratories1984-01-04
FACTOR II DEFICIENT SUBSTRATE PLASMA (K834031)Helena Laboratories1983-12-16
COLOSCREEN V.P.I. (K832864)Helena Laboratories1983-11-21
GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL (K833356)Helena Laboratories1983-11-03
PLATELET AGGREGATION REAGENT SET (K832428)Helena Laboratories1983-10-20
BIO SURE STAIN (K832496)Helena Laboratories1983-09-12
TITAN GEL GLYCO-HEME SYSTEM (K832087)Helena Laboratories1983-08-24
BIOCHECK POSITIVE URINE CONTROL (K831994)Helena Laboratories1983-08-08
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