Data / Medical devices / United States / Helena Laboratories, Corp.
Helena Laboratories, Corp.: FDA-registered device maker in Beaumont, TX, United States, 6 510(k) clearances
Helena Laboratories, Corp. is registered with the FDA (registration 1644474) in Beaumont, TX, United States. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 11, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1644474
- FEI number
- 1000116989
- Address
- 3795 Washington BLVD., Beaumont, TX, United States, 77705
- Owner or operator
- HELENA LABORATORIES, CORP. (1618982)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- July 23, 1987
- Registered through
- 2026
- Brand names listed
- 10-100 µLVariable Volume Pipette with Tip Ejector, 1000 Staining Set, 35uL Micropipette, Actalyke Mini II Analyzer, Actalyke Thermometer, Actalyke XL Analyzer, AggRAM Analyzer, AggRAM Module and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activated Whole Blood Clotting Time | JBP | 2 | Manufacturer | accessdata.fda.gov |
| Apparatus, Electrophoresis, For Clinical Use | JJN | 1 | Manufacturer | accessdata.fda.gov |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | 1 | Manufacturer | accessdata.fda.gov |
| Densitometeric, Protein Fractionation | JQJ | 1 | Manufacturer | accessdata.fda.gov |
| Electrophoretic, Protein Fractionation | CEF | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Fluorometric Measurement, Porphyrins | JKJ | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Coagulation, Automated | GKP | 2 | Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Manufacturer | accessdata.fda.gov |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2005 | K050053 | HEMORAM/AGGRAM ANALYZER | JPA | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 23, 2002 | K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | JBP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| January 10, 2002 | K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 | JBP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 27, 1997 | K972274 | SPIFE | CEF | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| August 23, 1993 | K931956 | CASCADE M, CAT. NO. 1710 | GKP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| November 17, 1989 | K893038 | PROTOFLUOR Z | JKJ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Station, Pipetting And Diluting, For Clinical Use
- All makers of Fluorometric Measurement, Porphyrins
- All makers of Activated Whole Blood Clotting Time
- All makers of Electrophoretic, Protein Fractionation
- All makers of Instrument, Coagulation, Automated
- All makers of Densitometeric, Protein Fractionation
Updated July 11, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.