Diatech, Inc.
US Last updated 23 May 2026
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- Devices
- 17
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Heparin Coagulation Control Plasma 1- Ref K841462
Dia Reptin Ref K841365
Calcium Chloride Ref K841522
Fibrinogen Test Ref K834571
Diatimer-1 Blood Plasma Clot Timing Instrument Ref K854089
Diacelin Ref K840288
Factor Deficient Substrate Plasma Viii Ref K840928
Coagulation Control Plasma Level 1/2/3 Ref K841461
Coascreener/Diascreenerblood Plasma Timing Inst. Ref K854938
Factor Deficient Substrate Plasma Ii Ref K840927
Owren's Veronal Bufferr Ref K841523
Fibrinogentest-O Ref K881685
Dia T1, T2 & T3 Ref K842286
Diatimer-2 Blood Plasma Clot Timing Instrument Ref K854090
Dia-H 1/2/3 & Dia-Ht 1/2/3 Ref K840801
Dia Fibrin Ref K841366
Dia Thrombin Dia Plastin Ref K840802
FDA establishments
- Diatech SRL IT
What Diatech, Inc. makes
Diatech, Inc. manufactures coagulation control plasmas, including heparin control, calcium chloride, and fibrinogen test reagents. The company also produces blood plasma timing instruments, such as the DIATIMER-1 and COASCREENER/DIASCREENER, as well as factor-deficient substrate plasmas for testing clotting factors VIII and II. Additional products include OWREN’s Veronal Buffer and specialized coagulation control plasmas at varying levels (1, 2, and 3).
These devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device regulations. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Diatech, Inc. manufacture?
Diatech, Inc. specializes in coagulation-related medical devices, primarily focused on plasma-based reagents and testing instruments. Their portfolio includes coagulation control plasmas (such as heparin control and varying levels of control plasmas), clotting factor-deficient substrates (e.g., for factors VIII and II), and specialized reagents like calcium chloride and fibrinogen tests. They also produce blood plasma timing instruments, such as the DIATIMER-1 and COASCREENER/DIASCREENER, which are used to measure clotting times in laboratory settings.
Where is Diatech, Inc. based, and how does that affect its regulatory compliance?
Diatech, Inc. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s 510(k) database, this indicates that their devices have undergone the necessary regulatory submissions (such as 510(k) clearances) to demonstrate compliance with U.S. medical device regulations before entering the market.
Which regulatory registries or databases list Diatech, Inc.’s devices?
Diatech, Inc.’s devices are listed in the FDA’s 510(k) database, which is a public registry of medical devices that have received 510(k) clearances. This database serves as a reference for authorized devices in the U.S., allowing healthcare professionals and regulators to verify that the products meet applicable safety and performance standards before commercial distribution.
How are Diatech, Inc.’s devices classified under FDA regulations?
Diatech, Inc.’s devices fall under both Class I and Class II classifications under the FDA’s regulatory framework. Class I devices generally pose the lowest risk and may be exempt from some pre-market submissions, while Class II devices require special controls to ensure their safety and effectiveness. Since these products are listed in the 510(k) database, they have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with applicable regulations.
Information
- Country
- US