Rapid Diagnostic Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Rapid Diagnostic Laboratories, Inc. makes
Rapid Diagnostic Laboratories, Inc. manufactures medical device controls and calibration tools, including cardiopulmonary bypass filters, drug mixture and cannabinoid controls, and blind controls for drug-of-abuse testing. Their portfolio also covers high-performance calibrators and specialized controls for laboratory testing environments.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Cobe Cop Filter Cardiopulmonary Prebypass Filter Ref K850139
Regimes: 510(k) Registry: 510(k)Hyperformance Controls (Hp-Controls) Ref K871694
Regimes: 510(k) Registry: 510(k)New Low Level Drug Mixture Control Ref K890030
Regimes: 510(k) Registry: 510(k)High Performance Calibrators Ref K875216
Regimes: 510(k) Registry: 510(k)High Performance Cannabinoid Controls Ref K863117
Regimes: 510(k) Registry: 510(k)Blind Controls For Drugs Of Abuse Testing Ref K903909
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rapid Diagnostic Laboratories, Inc. have in the registry?
The registry currently lists 6 devices for Rapid Diagnostic Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rapid Diagnostic Laboratories, Inc.'s devices?
Among its 6 most recently registered devices, Rapid Diagnostic Laboratories, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Rapid Diagnostic Laboratories, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Rapid Diagnostic Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rapid Diagnostic Laboratories, Inc. in the registry?
The most recently registered devices listed for Rapid Diagnostic Laboratories, Inc. include COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER, HYPERFORMANCE CONTROLS (HP-CONTROLS), NEW LOW LEVEL DRUG MIXTURE CONTROL and HIGH PERFORMANCE CALIBRATORS.