Monika Kathmeyer

FDA Filings

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

FDA Registration(s)
Registration Number3008156187
FEI Number3008156187
NameMonika Kathmeyer
Owner & OperatorTechno-path Manufacturing Ltd.
Contact AddressFort Henry Business Park
Ballina IE-TA Tipperary V94TR9X IE
US Agent
Importing Logistics Registration
ImporterNorthwell Core laboratories
Address10 Nevada Drive Lake Success.
Lake Success, NY 11042 UNITED STATES
Importer TypeEND USER
Importing Logistics Registration
ImporterNorthwell Core Laboratory
Address10 Nevada Drive Lake Success.
Lake Success, NY 11042 UNITED STATES
Importer TypeEND USER
Importing Logistics Registration
ImporterVA Medical Center 662
Address4150 Clement Street San Francisco
San Francisco, CA 94121 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address99 Lafayette Drive Suite 179
Syosset, NY 11791 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Plus (IA300A, 05P76-10, IA310A, IA311A, IA312A, IA313A)2017-04-03
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Plus (08P86-10)2017-04-03
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem A1c HB000A, HB001A, HB002A, HB000M, HB000T, HB001T, HB002T2016-10-27
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem A1c 04V06102016-10-27
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus CH100PLA, CH101PLA, CH102PLA, CH103PLA, CH110PLA.05, CH111PLA.05, CH112PLA.05, CH113PLA2013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus 05P78-10/11/122013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem WBT, 04S16-102013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem WBT WB000A2013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Plus, IA310A, IA311A, IA312A, IA313A,2013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Plus 05P76-102013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem U, 05P80-102013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem U UC201A.10 UC202A.102013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem P, SP41PA,2013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem P 05P812013-11-04
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem hsTn Unassayed HS301X/MX Assayed HS301A/MA2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem hsTn Assayed 04W26-102009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem WBT Unassayed WB000X2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem U Unassayed - UC201X, UC20BX, UC202X Assayed - UC201A.10, UC202A.102009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem U Assayed Alinity 08P89-102009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Unassayed CH101x/102X/103X/101X.05/102X.05/103X.052009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus Unassayed CH100/101/102/103CRP, CH/110/111/112/113/CRP.05 CH110MCRP.05, CH100MCRP2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus Unassayed Architect 05P79-10/11/122009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus Unassayed Alinity 08P87-10/11/122009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus Assayed CH100/101/102/103PLA CH110/111/112/113PLA.052009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Plus Assayed Alinity 08P88-10/11/122009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem S Assayed CH101/102/103A & CH101/102/102A.052009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem P Unassayed SP40PX2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem P Assayed Alinity 08P90-102009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem NB Unassayed NB800X Assayed NB800A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem ID-SeroNeg SR100N & SR100MN2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem ID-B SR101B & SR101MB2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Unassayed IA300X, IA301X, IA302X, IA303X Assayed IA301A, IA302A, IA303A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Speciality Unassayed BP300X, BP301X, BP302X, BP303X, BP300MX, Assayed BP300A/BP301A/BP302A/BP303A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem IA Plus Unassayed - IA310X, IA314X, IA311X, IA312X, IA313X IA310MX2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem D-Dimer Unassayed DM900X, DM900MX, DM901X, DM902X2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem D-Dimer Assayed DM900A, DM900MA, DM901A, DM902A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem CSF Unassayed CF100X, CF101X, CF102X, Multichem CSF Assayed CF100A, CF101A, CF102A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem AMH Unassayed AM500X/AM500MX2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem AMH Assayed AM500A/AM500MA2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem AE Unassayed Bilevel -AE600X, AE601X, AE602X, Trilevel - AE610X, AE611X, AE612X,AE613X2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem AE Trilevel Assayed AE610A, AE611A, AE612A, AE613A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
Multichem AE Assayed Bi Level AE600A, AE601A, AE602A2009-12-02
Monika Kathmeyer [Techno-path Manufacturing Ltd.]
MultiCHECK Cardiac Assayed 944-513/514/5152009-12-02

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