Gamma Medical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Gamma Medical Products, Inc. makes
Gamma Medical Products, Inc. manufactures the GAMMA CLQ, a device designed for quality control in radiopharmaceutical production, and the GMP CIQ ELISA Test Kit, used for detecting specific antibodies or antigens in immunoassay applications.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Gamma Clq Ref K823009
Regimes: 510(k) Registry: 510(k)Gmp Ciq Elisa Test Kit Ref K833275
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gamma Medical Products, Inc. have in the registry?
The registry currently lists 2 devices for Gamma Medical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gamma Medical Products, Inc.'s devices?
Among its 2 most recently registered devices, Gamma Medical Products, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gamma Medical Products, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gamma Medical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gamma Medical Products, Inc. in the registry?
The most recently registered devices listed for Gamma Medical Products, Inc. include GAMMA CLQ and GMP CIQ ELISA TEST KIT.