Iso-Data, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Iso-Data, Inc. makes
Iso-Data, Inc. manufactures laboratory equipment for nuclear medicine and immunoassay testing, including gamma counters (500 and 100 series), centrifuges (1-A, 101, 2D), and data reduction systems (IDI GDR). Their products also include a DPM (disintegrations per minute) calculator and an immunoassay network system for processing and analyzing test results.
The company’s devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) premarket notification database. These products are intended for use in clinical and research settings in the United States.
Catalogue
Iso-Data Immunoassay Network System Ref K843365
Regimes: 510(k) Registry: 510(k)Iso-Data Centrifuges 1-A, 101, 2D, Etc. Ref K843434
Regimes: 510(k) Registry: 510(k)Dpm Calculator Ref K810631
Regimes: 510(k) Registry: 510(k)Iso-Data 500 Series Gamma Counter Ref K872430
Regimes: 510(k) Registry: 510(k)Idi Gdr Data Reduction System Ref K780813
Regimes: 510(k) Registry: 510(k)Iso-Data 100 Series Gamma Counter Ref K872429
Regimes: 510(k) Registry: 510(k)Idi 200 Gamma Counter Ref K780790
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iso-Data, Inc. have in the registry?
The registry currently lists 7 devices for Iso-Data, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iso-Data, Inc.'s devices?
Among its 7 most recently registered devices, Iso-Data, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Iso-Data, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Iso-Data, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Iso-Data, Inc. in the registry?
The most recently registered devices listed for Iso-Data, Inc. include ISO-DATA IMMUNOASSAY NETWORK SYSTEM, ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC., DPM CALCULATOR and ISO-DATA 500 SERIES GAMMA COUNTER.