Hall/Mccollum Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Hall/Mccollum Laboratories, Inc. makes
Hall/McCollum Laboratories, Inc. manufactures sterile, single-use culture catheters designed for collecting and transporting clinical specimens, including the Pristine/Blooming/Pristine Blooming Culture Cath and Pristine Culture Catheter. These devices are intended for use in microbiological testing to isolate and identify pathogens from patient samples.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance. The devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements for their intended use.
Catalogue
Pristine/Blooming/Pristine Blooming Culture Cath Ref K862098
Regimes: 510(k) Registry: 510(k)Pristine Culture Catheter Ref K860325
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hall/Mccollum Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Hall/Mccollum Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hall/Mccollum Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Hall/Mccollum Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hall/Mccollum Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hall/Mccollum Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hall/Mccollum Laboratories, Inc. in the registry?
The most recently registered devices listed for Hall/Mccollum Laboratories, Inc. include PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH and PRISTINE CULTURE CATHETER.