Lafayette Pharmacal, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Lafayette Pharmacal, Inc. makes
Lafayette Pharmacal, Inc. manufactures gastrointestinal diagnostic and treatment devices, including the PRO-FLO system for fluid administration, the MAGLINTE enteroclysis catheter for intestinal contrast studies, and the ENTROKIT with MAGLINTE catheter for enteroclysis procedures. The company also produces SITZMARKS, a diagnostic marker used in radiographic imaging of the lower gastrointestinal tract.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions supported via 510(k) clearance. These products are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Pro-Flo System Ref K931896
Regimes: 510(k) Registry: 510(k)Maglinte Enteroclysis Catheter Ref K884379
Regimes: 510(k) Registry: 510(k)Entrokit With Maglinte Catheter Ref K860441
Regimes: 510(k) Registry: 510(k)Sitzmarks Ref K881609
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lafayette Pharmacal, Inc. have in the registry?
The registry currently lists 4 devices for Lafayette Pharmacal, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lafayette Pharmacal, Inc.'s devices?
Among its 4 most recently registered devices, Lafayette Pharmacal, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Lafayette Pharmacal, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Lafayette Pharmacal, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lafayette Pharmacal, Inc. in the registry?
The most recently registered devices listed for Lafayette Pharmacal, Inc. include PRO-FLO SYSTEM, MAGLINTE ENTEROCLYSIS CATHETER, ENTROKIT WITH MAGLINTE CATHETER and SITZMARKS.