Company ยท US
Helena Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2022. Name variants (Inc, Corp, punctuation) are merged.
282510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 19 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 18 |
| CEF | Electrophoretic, Protein Fractionation | 15 |
| JHO | Electrophoretic Separation, Lipoproteins | 15 |
| KHE | Reagent, Occult Blood | 14 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 12 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 12 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 11 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 9 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 8 |
| GHR | Reagent, Platelet Aggregation | 8 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 8 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 7 |
| GGN | Plasma, Coagulation Control | 7 |
| GJS | Test, Time, Prothrombin | 6 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 |
| JPD | Hemoglobin A2 Quantitation | 6 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 5 |
| GKP | Instrument, Coagulation, Automated | 5 |
| GFO | Activated Partial Thromboplastin | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2022 | K213396 | SPIFE A1AT kit Helena Laboratories, Corp. | OBZ |
| Apr 19, 2022 | K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control Helena Laboratories, Corp. | GKA |
| Oct 7, 2013 | K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL Helena Laboratories | JJY |
| Dec 15, 2010 | K100103 | SPECIALTY ASSAYED CONTROL-2 Helena Laboratories | GGC |
| Feb 23, 2007 | K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA Helena Laboratories | GHR |
| Jul 6, 2006 | K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 Helena Laboratories | CFF |
| May 10, 2006 | K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP Helena Laboratories | JPA |
| Jul 11, 2005 | K050053 | HEMORAM/AGGRAM ANALYZER Helena Laboratories | JPA |
| Feb 19, 2003 | K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 Helena Laboratories | CFF |
| Feb 14, 2003 | K023761 | PLATELETWORKS, MODELS PW-A, PW-C Helena Laboratories | JOZ |
| Oct 11, 2002 | K022757 | SPIFE CK KIT, MODEL 3332, 3333 Helena Laboratories | JHY |
| Oct 1, 2002 | K022455 | SPIFE LD-12 KIT, MODEL 3338 Helena Laboratories | CFE |
| Aug 15, 2002 | K022333 | SPIFE LIPPOROTEIN-12, MODEL 3344 Helena Laboratories | JHO |
| May 23, 2002 | K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 Helena Laboratories | JBP |
| May 6, 2002 | K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 Helena Laboratories | CIN |
| Mar 29, 2002 | K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 Helena Laboratories | CFE |
| Jan 10, 2002 | K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 Helena Laboratories | JBP |
| Dec 21, 2001 | K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 Helena Laboratories | JHO |
| Sep 28, 2001 | K012723 | PLATELETWORKS Helena Laboratories | JOZ |
| Mar 15, 2001 | K010617 | SPIFE IFE CALIBRATOR AND CONTROL KIT Helena Laboratories | DEW |
| Nov 27, 2000 | K003359 | COLOSCREEN-ES Helena Laboratories | KHE |
| Apr 17, 2000 | K000603 | SPIFE CHOLESTEROL PROFILE KIT Helena Laboratories | JHO |
| Oct 18, 1999 | K992971 | REP CHOLESTEROL PROFILE KIT Helena Laboratories | JHO |
| Sep 21, 1999 | K992199 | ACID HEMOGLOBIN KIT Helena Laboratories | JBD |
| Jun 28, 1999 | K990998 | POLYSLIT IFE KIT Helena Laboratories | CFF |
| Dec 17, 1998 | K982426 | SPIFE ALKALINE HEMOGLOBIN Helena Laboratories | JBD |
| Nov 4, 1998 | K982639 | SPIFE URINE IFE Helena Laboratories | DAO |
| May 12, 1998 | K980671 | COLOSCREEN-ES Helena Laboratories | KHE |
| May 1, 1998 | K980650 | REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL Helena Laboratories | JHO |
| Jan 6, 1998 | K974609 | REP CHOLESTEROL PROFILE CONTROL-II Helena Laboratories | JJX |
| Jan 2, 1998 | K973040 | SPIFE IFE-6 Helena Laboratories | CFF |
| Oct 27, 1997 | K972274 | SPIFE Helena Laboratories | CEF |
| Oct 1, 1997 | K973316 | REP SPE VIS-60/40 KIT Helena Laboratories | CEF |
| Jan 13, 1997 | K962914 | REP 3 QUTO-FLUR CHOLESTEROL-30 Helena Laboratories | JHO |
| Dec 23, 1996 | K964471 | REP FLUR CHOLESTEROL-60 KIT Helena Laboratories | JHO |
| Dec 23, 1996 | K964453 | REP 3 FLUR SPE-60 KIT Helena Laboratories | CEF |
| Dec 10, 1996 | K961908 | THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 Helena Laboratories | JPA |
| Oct 25, 1996 | K960571 | RAPID ELECTROPHORESIS ANALYZER Helena Laboratories | JHO |
| Mar 11, 1996 | K952321 | PORCINE FACTOR VIII;C REAGENT Helena Laboratories | GGN |
| Feb 14, 1996 | K952667 | CHROM Z-HEPARIN, CAT. NO 5242 Helena Laboratories | KFF |
| Feb 9, 1996 | K952668 | CHROM Z-F:VIII, CAT. NO. 5241 Helena Laboratories | GGP |
| Jan 30, 1996 | K952666 | CHROM Z-PROTEIN C, CAT. NO. 5243 Helena Laboratories | GGP |
| Dec 7, 1995 | K952669 | CHROM Z-PLASMINOGEN, CAT. NO. 5244 Helena Laboratories | GGP |
| Nov 13, 1995 | K951943 | CHROM Z CHROMOGENIC ASSAYS Helena Laboratories | JBQ |
| Oct 20, 1995 | K951820 | THROMBOPLASTIN-LI REAGENT Helena Laboratories | GJS |
| Sep 8, 1995 | K952252 | ADP REAGENT, MODIFIED Helena Laboratories | GHR |
| Sep 1, 1995 | K951497 | CASCASE 480 SNSLYZER Helena Laboratories | JPA |
| Jul 11, 1995 | K946274 | COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN Helena Laboratories | LCP |
| Mar 30, 1995 | K950801 | CARDIO REP LD CONTROL - CAT NO. 3325 Helena Laboratories | JJT |
| Mar 30, 1995 | K950590 | REP CHOLESTEROL PROFILE CONTROL Helena Laboratories | JJX |
Newest 50 of 282.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2023 | Helena Laboratories, Corp. Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics Open, Classified |
LXG | None listed |
| Apr 6, 2022 | Helena Laboratories, Corp. V8 Immunodisplacement Kit REF 1803 Open, Classified |
CFF | K111369 |
| Jan 5, 2021 | Helena Laboratories, Corp. Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated wh Terminated |
GFO | None listed |
| Nov 9, 2020 | Helena Laboratories, Corp. K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. Open, Classified |
JPA | K013078 K061014 |
| Sep 27, 2019 | Helena Laboratories, Corp. Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX. Terminated |
GFO | None listed |
| Aug 8, 2018 | Helena Laboratories, Corp. ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Open, Classified |
KHE | K882799 |
| Aug 8, 2018 | Helena Laboratories, Corp. ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Open, Classified |
KHE | K882799 |
| May 23, 2018 | Helena Laboratories, Corp. Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use, Open, Classified |
GHR | K910706 |
| May 23, 2018 | Helena Laboratories, Corp. Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine ten Open, Classified |
GHR | K910706 |
| Feb 27, 2018 | Helena Laboratories, Corp. SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415,
for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems Open, Classified |
JBD | K982426 |
| Jul 21, 2017 | Helena Laboratories, Corp. SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Terminated |
CFF | K973040 |
| Apr 4, 2017 | Helena Laboratories, Inc. "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Refer Terminated |
GGP | K972482 |
| Feb 24, 2017 | Helena Laboratories, Inc. Cascade Abrazo c-ACT-LR Test Card
IVD FOR IN VITRO DIAGNOSTIC USE
Store at 2 to 8 C
HELENA LABORATORIES
003366
12/13(2)
FOR EXPORT ONLY Terminated |
JPB | None listed |
| Nov 7, 2016 | Helena Laboratories, Inc. Gel Alkaline Phosphatase Isoenzyme Control Kit:
Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE
Gel Alkaline Phosphatase Isoenzyme Control 20mL 0018 Terminated |
JJX | K895528 |
| Oct 14, 2016 | Helena Laboratories, Inc. Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL Terminated |
JJY | K821982 |
| Apr 20, 2016 | Helena Laboratories, Inc. Cascade Abrazo c-ACT-LR Test Card
IVD FOR IN VITRO DIAGNOSTIC USE
Store at 2 to 8 C
HELENA LABORATORIES
003366
12/13(2)
FOR EXPORT ONLY
The Cascade Abrazo c-ACT-LR test cards are activated clotting Terminated |
JPB | None listed |