Data / Medical devices / Ireland / Tcoag Ireland Limited
Tcoag Ireland Limited: FDA-registered device maker in BRAY Wicklow, Ireland, 25 510(k) clearances
Tcoag Ireland Limited is registered with the FDA (registration 3008386529) in BRAY Wicklow, Ireland. It lists 14 device types. The FDA files 25 510(k) clearances under its listings, the newest dated November 15, 2001. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008386529
- Address
- Ida Business Park Southern Cross Road, BRAY Wicklow, Ireland, --
- Owner or operator
- Tcoag Ireland Limited (10032571)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- May 28, 2010
- Registered through
- 2027
- Brand names listed
- D-Dimer Control Level 2, D-Dimer Control Level 3, DT Fluid (DTF), DT Wash (DTW), Ristocetin, STA - Cleaner Solution (00973), STA - Desorb U (00975), STA® - Owren Koller and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| November 15, 2001 | K013545 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 | DAP | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| November 15, 2001 | K013544 | SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 | DAP | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| October 9, 1997 | K971858 | SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) | KQJ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| July 25, 1997 | K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | JBQ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| November 18, 1996 | K963106 | CHROMOLIZE PAI-1 KIT | GGP | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 5, 1996 | K960438 | TINTELIZE PAI-1 KIT | GGP | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| May 17, 1994 | K935308 | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY | JBQ | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| December 6, 1993 | K934584 | SPECTROLYSE FACTOR VII:C | GGP | Substantially Equivalent | Meditech, Inc. | accessdata.fda.gov |
| April 20, 1993 | K930849 | VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA | JPA | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| October 19, 1992 | K921396 | PLATELIN L | GFO | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| October 22, 1990 | K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | GGC | Substantially Equivalent | Medi-Tech, Inc. | accessdata.fda.gov |
| March 27, 1990 | K900792 | RISTOCETIN | GHR | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| January 25, 1990 | K900133 | FACTOR II DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| November 9, 1989 | K896052 | FIBRINOGEN ASSAY KIT | KQJ | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| October 6, 1989 | K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT | GFO | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893536 | FACTOR XI DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893535 | FACTOR VII DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893534 | FACTOR XII DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893533 | FACTOR V DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893525 | FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893524 | FACTOR IX DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893523 | FACTOR X DEFICIENT PLASMA | GJT | Substantially Equivalent | Medical Diagnostic Technologies, Inc. | accessdata.fda.gov |
| August 17, 1988 | K881999 | PLATELIN(R) EXCEL L | GIT | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| July 1, 1988 | K882214 | SIMPLASTIN EXCEL S | GJS | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
| May 2, 1988 | K881348 | VERIFY(R) REFERENCE PLASMA | GGN | Substantially Equivalent | Organon Teknika Corp. | accessdata.fda.gov |
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Updated November 15, 2001. 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.