Accu-Stat Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Accu-Stat Diagnostics, Inc. makes
Accu-Stat Diagnostics, Inc. manufactures home drug testing devices that detect the presence of specific substances in urine samples, including THC (marijuana), cocaine, amphetamine, methamphetamine, opiates, and phencyclidine. The tests are designed for point-of-use screening in non-laboratory settings, providing qualitative results for individual substances or combinations of drugs.
The company’s portfolio includes Class II and unclassified (Class U) devices, all of which are subject to FDA 510(k) clearance requirements. These products are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Accu-Stat Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, And Phencyclidine Ref K040629
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accu-Stat Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Accu-Stat Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accu-Stat Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Accu-Stat Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Accu-Stat Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Accu-Stat Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Accu-Stat Diagnostics, Inc. in the registry?
The most recently registered devices listed for Accu-Stat Diagnostics, Inc. include ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC), ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY and ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE.