Gotham Biologics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Gotham Biologics, Inc. makes
Gotham Biologics, Inc. manufactures bovine albumin solutions at concentrations of 22% and 30%, used primarily as plasma volume expanders and protein supplements in medical treatments. The company also produces an RH-HR negative control reagent, designed for use in blood typing and compatibility testing.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Bovine Albumin 22% & 30% Solutions Ref K800189
Regimes: 510(k) Registry: 510(k)Rh-Hr Negative Control Reagent Ref K800239
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gotham Biologics, Inc. have in the registry?
The registry currently lists 2 devices for Gotham Biologics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gotham Biologics, Inc.'s devices?
Among its 2 most recently registered devices, Gotham Biologics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Gotham Biologics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gotham Biologics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gotham Biologics, Inc. in the registry?
The most recently registered devices listed for Gotham Biologics, Inc. include BOVINE ALBUMIN 22% & 30% SOLUTIONS and RH-HR NEGATIVE CONTROL REAGENT.