Data / Medical devices / Ireland / Techno-Path Manufacturing Ltd.
Techno-Path Manufacturing Ltd.: FDA-registered device maker in Ballina Tipperary, Ireland, 7 510(k) clearances
Techno-Path Manufacturing Ltd. is registered with the FDA (registration 3008156187) in Ballina Tipperary, Ireland. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 31, 2017. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008156187
- Address
- Fort Henry Business Park, Ballina Tipperary, Ireland, V94 FF1P
- Owner or operator
- Techno-path Manufacturing Ltd. (10030933)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- December 2, 2009
- Registered through
- 2026
- Brand names listed
- Multichem A1c 04V0610, Multichem A1c HB000A, HB001A, HB002A, HB000M, Multichem A1c HB000A, HB001A, HB002A, HB000M, 04V06-10, Multichem AE 06S7861, 06S7862, 06S7863, Multichem AE AE621A, AE622A, AE623A, Multichem AE AE621X, AE622X, AE623X, Multichem AE Assayed Bi Level AE600A, AE601A, AE602A, Multichem AE Trilevel Assayed AE610A, AE611A, AE612A, AE613A and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assayed Quality Control Material For Clinical Microbiology Assays | QCH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Drug Mixture Control Materials | DIF | 1 | Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 31, 2017 | K162530 | Multichem IA Plus | JJY | Substantially Equivalent | Techno-Path Manufacturing | accessdata.fda.gov |
| October 26, 2016 | K162514 | Multichem A1c | JJX | Substantially Equivalent | Technopath Manufacturing | accessdata.fda.gov |
| October 22, 2013 | K132751 | MULTICHEM S PLUS / S PLUS (ASSAYED) | JJY | Substantially Equivalent | Techno-Path Manufacturing , Ltd. | accessdata.fda.gov |
| October 15, 2013 | K131993 | MULTICHEM U | JJY | Substantially Equivalent | Techno-Path Manufacturing , Ltd. | accessdata.fda.gov |
| September 25, 2013 | K131992 | MULTICHEM P | JJY | Substantially Equivalent | Techno-Path Manufacturing , Ltd. | accessdata.fda.gov |
| September 20, 2013 | K132174 | MULTICHEM WBT | DIF | Substantially Equivalent | Techno-Path Manufacturing , Ltd. | accessdata.fda.gov |
| September 20, 2013 | K132091 | MULTICHEM IA AND IA PLUS | JJY | Substantially Equivalent | Techno-Path Manufacturing , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 14, 2026 | 99724 | Class II | Ongoing | Techno-Path Multichem AE Unassayed Level 1 REF:AE621X | A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. T | accessdata.fda.gov |
| October 17, 2025 | 97800 | Class II | Ongoing | Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, | Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. | accessdata.fda.gov |
| August 25, 2023 | 93017 | Class II | Ongoing | Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breaka | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Assayed Quality Control Material For Clinical Microbiology Assays
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Drug Mixture Control Materials
- All makers of Multi-Analyte Controls Unassayed
Updated October 22, 2026. 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.