Helena Laboratories

FDA Filings

This page includes the latest FDA filings for Helena Laboratories. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K131479 HELENA LABORATORIES	V8 SP NORMAL CONTROL, ABNORMAL CONTROL	2013-10-07
PMN K100103 HELENA LABORATORIES	SPECIALTY ASSAYED CONTROL-2	2010-12-15
PMN K061991 HELENA LABORATORIES	PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA	2007-02-23
PMN K061069 HELENA LABORATORIES	SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458	2006-07-06
PMN K061014 HELENA LABORATORIES	ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP	2006-05-10
PMN K050053 HELENA LABORATORIES	HEMORAM/AGGRAM ANALYZER	2005-07-11
PMN K024162 HELENA LABORATORIES	SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389	2003-02-19
PMN K023761 HELENA LABORATORIES	PLATELETWORKS, MODELS PW-A, PW-C	2003-02-14
PMN K022757 HELENA LABORATORIES	SPIFE CK KIT, MODEL 3332, 3333	2002-10-11
PMN K022455 HELENA LABORATORIES	SPIFE LD-12 KIT, MODEL 3338	2002-10-01
PMN K022333 HELENA LABORATORIES	SPIFE LIPPOROTEIN-12, MODEL 3344	2002-08-15
PMN K020914 HELENA LABORATORIES	ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770	2002-05-23
PMN K020625 HELENA LABORATORIES	SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346	2002-05-06
PMN K020467 HELENA LABORATORIES	SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452	2002-03-29
PMN K013078 HELENA LABORATORIES	ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752	2002-01-10
PMN K013466 HELENA LABORATORIES	SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343	2001-12-21
PMN K012723 HELENA LABORATORIES	PLATELETWORKS	2001-09-28
PMN K003359 HELENA LABORATORIES	COLOSCREEN-ES	2000-11-27
PMN K000603 HELENA LABORATORIES	SPIFE CHOLESTEROL PROFILE KIT	2000-04-17
PMN K992971 HELENA LABORATORIES	REP CHOLESTEROL PROFILE KIT	1999-10-18
PMN K992199 HELENA LABORATORIES	ACID HEMOGLOBIN KIT	1999-09-21
PMN K990998 HELENA LABORATORIES	POLYSLIT IFE KIT	1999-06-28
PMN K982426 HELENA LABORATORIES	SPIFE ALKALINE HEMOGLOBIN	1998-12-17
PMN K982639 HELENA LABORATORIES	SPIFE URINE IFE	1998-11-04
PMN K980671 HELENA LABORATORIES	COLOSCREEN-ES	1998-05-12
PMN K980650 HELENA LABORATORIES	REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL	1998-05-01
PMN K974609 HELENA LABORATORIES	REP CHOLESTEROL PROFILE CONTROL-II	1998-01-06
PMN K973040 HELENA LABORATORIES	SPIFE IFE-6	1998-01-02
PMN K972274 HELENA LABORATORIES	SPIFE	1997-10-27
PMN K973316 HELENA LABORATORIES	REP SPE VIS-60/40 KIT	1997-10-01
PMN K962914 HELENA LABORATORIES	REP 3 QUTO-FLUR CHOLESTEROL-30	1997-01-13
PMN K964471 HELENA LABORATORIES	REP FLUR CHOLESTEROL-60 KIT	1996-12-23
PMN K964453 HELENA LABORATORIES	REP 3 FLUR SPE-60 KIT	1996-12-23
PMN K961908 HELENA LABORATORIES	THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451	1996-12-10
PMN K960571 HELENA LABORATORIES	RAPID ELECTROPHORESIS ANALYZER	1996-10-25
PMN K952321 HELENA LABORATORIES	PORCINE FACTOR VIII;C REAGENT	1996-03-11
PMN K952667 HELENA LABORATORIES	CHROM Z-HEPARIN, CAT. NO 5242	1996-02-14
PMN K952668 HELENA LABORATORIES	CHROM Z-F:VIII, CAT. NO. 5241	1996-02-09
PMN K952666 HELENA LABORATORIES	CHROM Z-PROTEIN C, CAT. NO. 5243	1996-01-30
PMN K952669 HELENA LABORATORIES	CHROM Z-PLASMINOGEN, CAT. NO. 5244	1995-12-07
PMN K951943 HELENA LABORATORIES	CHROM Z CHROMOGENIC ASSAYS	1995-11-13
PMN K951820 HELENA LABORATORIES	THROMBOPLASTIN-LI REAGENT	1995-10-20
PMN K952252 HELENA LABORATORIES	ADP REAGENT, MODIFIED	1995-09-08
PMN K951497 HELENA LABORATORIES	CASCASE 480 SNSLYZER	1995-09-01
PMN K946274 HELENA LABORATORIES	COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN	1995-07-11
PMN K950801 HELENA LABORATORIES	CARDIO REP LD CONTROL - CAT NO. 3325	1995-03-30
PMN K950590 HELENA LABORATORIES	REP CHOLESTEROL PROFILE CONTROL	1995-03-30
PMN K935169 HELENA LABORATORIES	APTT-ES	1994-12-02
PMN K941872 HELENA LABORATORIES	SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302	1994-11-21
PMN K935162 HELENA LABORATORIES	REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT	1994-11-10
PMN K933086 HELENA LABORATORIES	AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328	1994-10-31
PMN K941737 HELENA LABORATORIES	SPECIALTY ASSAYED CONTROL-1	1994-10-07
PMN K941860 HELENA LABORATORIES	SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)	1994-09-14
PMN K940679 HELENA LABORATORIES	REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222	1994-09-09
PMN K940224 HELENA LABORATORIES	CARDIO REP LD	1994-08-17
PMN K940310 HELENA LABORATORIES	HELENA THROMBOPLASTIN-MI REAGENT	1994-04-20
PMN K933277 HELENA LABORATORIES	COAGULATION A.R.P.	1994-03-22
PMN K932442 HELENA LABORATORIES	CARDIO REP RECOMBINANT CK ABNORMAL CONTROL	1993-10-28
PMN K932768 HELENA LABORATORIES	CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323	1993-10-18
PMN K931956 HELENA LABORATORIES	CASCADE M, CAT. NO. 1710	1993-08-23
PMN K931503 HELENA LABORATORIES	REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)	1993-08-16
PMN K930317 HELENA LABORATORIES	REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278	1993-08-03
PMN K931465 HELENA LABORATORIES	REP ALKALINE HB-15 #3196,-8 #3197,-4 3198	1993-07-06
PMN K931247 HELENA LABORATORIES	TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067	1993-04-27
PMN K931050 HELENA LABORATORIES	CARDIO REP CK ISOENZYME KIT - 3310	1993-04-20
PMN K930359 HELENA LABORATORIES	CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305	1993-04-12
PMN K926222 HELENA LABORATORIES	OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376	1993-02-12
PMN K925801 HELENA LABORATORIES	REP E-Z CK-30 ISOENZYME KIT	1992-12-28
PMN K924915 HELENA LABORATORIES	SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479	1992-12-18
PMN K923658 HELENA LABORATORIES	REP IMMUNOFIX	1992-11-02
PMN K921578 HELENA LABORATORIES	TITAN GEL ALKALINE PHOSPHATASE (HR)	1992-09-23
PMN K923318 HELENA LABORATORIES	COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL	1992-08-25
PMN K923317 HELENA LABORATORIES	COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL	1992-08-25
PMN K922053 HELENA LABORATORIES	REP SPE PLUS (PONCEAU S) SYSTEM	1992-08-18
PMN K920820 HELENA LABORATORIES	MODIFICATION COLUMNMATE	1992-08-17
PMN K922024 HELENA LABORATORIES	REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175	1992-07-23
PMN K921676 HELENA LABORATORIES	COLUMNMATE II	1992-07-10
PMN K921465 HELENA LABORATORIES	CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)	1992-06-29
PMN K920927 HELENA LABORATORIES	KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024	1992-06-19
PMN K921363 HELENA LABORATORIES	CASCADE 480	1992-06-09
PMN K921305 HELENA LABORATORIES	GLYCO-TEK AFFINITY COLUMN KIT	1992-06-09
PMN K920926 HELENA LABORATORIES	KEMTROL SERUM CONTROL-ABNORMAL	1992-05-07
PMN K920147 HELENA LABORATORIES	THROMBIN CLOTTING TIME REAGENT	1992-05-01
PMN K914949 HELENA LABORATORIES	COAGULATION ARPR,CAT.NO.5185	1992-03-04
PMN K915418 HELENA LABORATORIES	ELLAGIC ACID APTT REAGENT	1992-02-14
PMN K914946 HELENA LABORATORIES	CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION	1992-01-13
PMN K913384 HELENA LABORATORIES	COLUMNMATE(TM) BETA-THAL CAT. NO. 4515	1991-12-17
PMN K913807 HELENA LABORATORIES	REP(R) SPE TEMPLATE 30, 16, & 8	1991-11-27
PMN K913058 HELENA LABORATORIES	REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172	1991-10-30
PMN K912774 HELENA LABORATORIES	ARACHIDONIC ACID	1991-08-22
PMN K911777 HELENA LABORATORIES	ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED	1991-08-22
PMN K912201 HELENA LABORATORIES	PACKS-4 (TM) ANALYZER	1991-08-16
PMN K912603 HELENA LABORATORIES	REP ALP-15, 8, & 4 KITS	1991-07-30
PMN K912386 HELENA LABORATORIES	REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165	1991-07-17
PMN K911075 HELENA LABORATORIES	COLOSCREEN	1991-07-03
PMN K905798 HELENA LABORATORIES	COLOCARE	1991-07-03
PMN K910800 HELENA LABORATORIES	ADP REAGENT	1991-05-20
PMN K910706 HELENA LABORATORIES	COLLAGEN REAGENT CAT. NO. 5368	1991-05-20

Similar & Related FDA Registered Companies

• HELENA LABORATORIES, CORP.
• HELENA LABORATORIES UK LTD

Related Finance Registrations

NCAGE Code	4K136	HELENA LABORATORIES
CAGE Code	4K136	HELENA LABORATORIES