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Helena Laboratories

280 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
V8 SP NORMAL CONTROL, ABNORMAL CONTROL (K131479)Helena Laboratories2013-10-07
SPECIALTY ASSAYED CONTROL-2 (K100103)Helena Laboratories2010-12-15
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (K061991)Helena Laboratories2007-02-23
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 (K061069)Helena Laboratories2006-07-06
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (K061014)Helena Laboratories2006-05-10
HEMORAM/AGGRAM ANALYZER (K050053)Helena Laboratories2005-07-11
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (K024162)Helena Laboratories2003-02-19
PLATELETWORKS, MODELS PW-A, PW-C (K023761)Helena Laboratories2003-02-14
SPIFE CK KIT, MODEL 3332, 3333 (K022757)Helena Laboratories2002-10-11
SPIFE LD-12 KIT, MODEL 3338 (K022455)Helena Laboratories2002-10-01
SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333)Helena Laboratories2002-08-15
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (K020914)Helena Laboratories2002-05-23
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (K020625)Helena Laboratories2002-05-06
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (K020467)Helena Laboratories2002-03-29
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (K013078)Helena Laboratories2002-01-10
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 (K013466)Helena Laboratories2001-12-21
PLATELETWORKS (K012723)Helena Laboratories2001-09-28
SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617)Helena Laboratories2001-03-15
COLOSCREEN-ES (K003359)Helena Laboratories2000-11-27
SPIFE CHOLESTEROL PROFILE KIT (K000603)Helena Laboratories2000-04-17
REP CHOLESTEROL PROFILE KIT (K992971)Helena Laboratories1999-10-18
ACID HEMOGLOBIN KIT (K992199)Helena Laboratories1999-09-21
POLYSLIT IFE KIT (K990998)Helena Laboratories1999-06-28
SPIFE ALKALINE HEMOGLOBIN (K982426)Helena Laboratories1998-12-17
SPIFE URINE IFE (K982639)Helena Laboratories1998-11-04
COLOSCREEN-ES (K980671)Helena Laboratories1998-05-12
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL (K980650)Helena Laboratories1998-05-01
REP CHOLESTEROL PROFILE CONTROL-II (K974609)Helena Laboratories1998-01-06
SPIFE IFE-6 (K973040)Helena Laboratories1998-01-02
SPIFE (K972274)Helena Laboratories1997-10-27
REP SPE VIS-60/40 KIT (K973316)Helena Laboratories1997-10-01
REP 3 QUTO-FLUR CHOLESTEROL-30 (K962914)Helena Laboratories1997-01-13
REP 3 FLUR SPE-60 KIT (K964453)Helena Laboratories1996-12-23
REP FLUR CHOLESTEROL-60 KIT (K964471)Helena Laboratories1996-12-23
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 (K961908)Helena Laboratories1996-12-10
RAPID ELECTROPHORESIS ANALYZER (K960571)Helena Laboratories1996-10-25
PORCINE FACTOR VIII;C REAGENT (K952321)Helena Laboratories1996-03-11
CHROM Z-HEPARIN, CAT. NO 5242 (K952667)Helena Laboratories1996-02-14
CHROM Z-F:VIII, CAT. NO. 5241 (K952668)Helena Laboratories1996-02-09
CHROM Z-PROTEIN C, CAT. NO. 5243 (K952666)Helena Laboratories1996-01-30
CHROM Z-PLASMINOGEN, CAT. NO. 5244 (K952669)Helena Laboratories1995-12-07
CHROM Z CHROMOGENIC ASSAYS (K951943)Helena Laboratories1995-11-13
THROMBOPLASTIN-LI REAGENT (K951820)Helena Laboratories1995-10-20
ADP REAGENT, MODIFIED (K952252)Helena Laboratories1995-09-08
CASCASE 480 SNSLYZER (K951497)Helena Laboratories1995-09-01
COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN (K946274)Helena Laboratories1995-07-11
REP CHOLESTEROL PROFILE CONTROL (K950590)Helena Laboratories1995-03-30
CARDIO REP LD CONTROL - CAT NO. 3325 (K950801)Helena Laboratories1995-03-30
APTT-ES (K935169)Helena Laboratories1994-12-02
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 (K941872)Helena Laboratories1994-11-21
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT (K935162)Helena Laboratories1994-11-10
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (K933086)Helena Laboratories1994-10-31
SPECIALTY ASSAYED CONTROL-1 (K941737)Helena Laboratories1994-10-07
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) (K941860)Helena Laboratories1994-09-14
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 (K940679)Helena Laboratories1994-09-09
CARDIO REP LD (K940224)Helena Laboratories1994-08-17
HELENA THROMBOPLASTIN-MI REAGENT (K940310)Helena Laboratories1994-04-20
COAGULATION A.R.P. (K933277)Helena Laboratories1994-03-22
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL (K932442)Helena Laboratories1993-10-28
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 (K932768)Helena Laboratories1993-10-18
CASCADE M, CAT. NO. 1710 (K931956)Helena Laboratories1993-08-23
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (K931503)Helena Laboratories1993-08-16
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 (K930317)Helena Laboratories1993-08-03
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (K931465)Helena Laboratories1993-07-06
TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (K931247)Helena Laboratories1993-04-27
CARDIO REP CK ISOENZYME KIT - 3310 (K931050)Helena Laboratories1993-04-20
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 (K930359)Helena Laboratories1993-04-12
OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 (K926222)Helena Laboratories1993-02-12
REP E-Z CK-30 ISOENZYME KIT (K925801)Helena Laboratories1992-12-28
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 (K924915)Helena Laboratories1992-12-18
REP IMMUNOFIX (K923658)Helena Laboratories1992-11-02
TITAN GEL ALKALINE PHOSPHATASE (HR) (K921578)Helena Laboratories1992-09-23
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (K923317)Helena Laboratories1992-08-25
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (K923318)Helena Laboratories1992-08-25
REP SPE PLUS (PONCEAU S) SYSTEM (K922053)Helena Laboratories1992-08-18
MODIFICATION COLUMNMATE (K920820)Helena Laboratories1992-08-17
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 (K922024)Helena Laboratories1992-07-23
COLUMNMATE II (K921676)Helena Laboratories1992-07-10
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) (K921465)Helena Laboratories1992-06-29
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 (K920927)Helena Laboratories1992-06-19
CASCADE 480 (K921363)Helena Laboratories1992-06-09
GLYCO-TEK AFFINITY COLUMN KIT (K921305)Helena Laboratories1992-06-09
KEMTROL SERUM CONTROL-ABNORMAL (K920926)Helena Laboratories1992-05-07
THROMBIN CLOTTING TIME REAGENT (K920147)Helena Laboratories1992-05-01
COAGULATION ARPR,CAT.NO.5185 (K914949)Helena Laboratories1992-03-04
ELLAGIC ACID APTT REAGENT (K915418)Helena Laboratories1992-02-14
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION (K914946)Helena Laboratories1992-01-13
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (K913384)Helena Laboratories1991-12-17
REP(R) SPE TEMPLATE 30, 16, & 8 (K913807)Helena Laboratories1991-11-27
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058)Helena Laboratories1991-10-30
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED (K911777)Helena Laboratories1991-08-22
ARACHIDONIC ACID (K912774)Helena Laboratories1991-08-22
PACKS-4 (TM) ANALYZER (K912201)Helena Laboratories1991-08-16
REP ALP-15, 8, & 4 KITS (K912603)Helena Laboratories1991-07-30
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 (K912386)Helena Laboratories1991-07-17
COLOCARE (K905798)Helena Laboratories1991-07-03
COLOSCREEN (K911075)Helena Laboratories1991-07-03
ADP REAGENT (K910800)Helena Laboratories1991-05-20
COLLAGEN REAGENT CAT. NO. 5368 (K910706)Helena Laboratories1991-05-20
EPINEPHRINE REAGENT, CAT. NO. 5367 (K910680)Helena Laboratories1991-05-20
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