Pearce Clinical Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Pearce Clinical Laboratories, Inc. makes
Pearce Clinical Laboratories, Inc. develops in vitro diagnostic devices for assessing individual risk of diabetes and colorectal cancer, as well as detecting hypertension risk. These tests are designed to provide early indicators for potential health conditions based on patient-specific biomarkers or clinical data.
The company’s portfolio is regulated under Class II devices in the US, with products authorised via the FDA’s 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their compliance with applicable regulatory requirements. The company operates within the United States.
Catalogue
Diabetes Risk Detector Ref K864544
Regimes: 510(k) Registry: 510(k)Colorectal Cancer Risk Detector (Tm) Ref K874180
Regimes: 510(k) Registry: 510(k)Hypertension Risk Detector(Tm) Ref K871482
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pearce Clinical Laboratories, Inc. have in the registry?
The registry currently lists 3 devices for Pearce Clinical Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pearce Clinical Laboratories, Inc.'s devices?
Among its 3 most recently registered devices, Pearce Clinical Laboratories, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Pearce Clinical Laboratories, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Pearce Clinical Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pearce Clinical Laboratories, Inc. in the registry?
The most recently registered devices listed for Pearce Clinical Laboratories, Inc. include DIABETES RISK DETECTOR, COLORECTAL CANCER RISK DETECTOR (TM) and HYPERTENSION RISK DETECTOR(TM).