Arden Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Arden Medical Systems, Inc. makes
Arden Medical Systems, Inc. manufactures clinical chemistry controls, including the CHEMPRO 1000™ system and A-QC control products. These devices are designed for quality assurance in laboratory testing, ensuring accurate measurement of biochemical parameters in patient samples.
The company’s portfolio includes Class I and Class II devices, all of which are listed under the FDA’s 510(k) pathway. Arden Medical Systems, Inc. is based in the United States.
Catalogue
Chempro 1000(Tm) Ref K870860
Regimes: 510(k) Registry: 510(k)A-Qc Clinical Chemistry Control Ref K873611
Regimes: 510(k) Registry: 510(k)A.qc Chemistry Control Level 2 Ref K883012
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Arden Medical Systems, Inc. have in the registry?
The registry currently lists 3 devices for Arden Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arden Medical Systems, Inc.'s devices?
Among its 3 most recently registered devices, Arden Medical Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Arden Medical Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Arden Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Arden Medical Systems, Inc. in the registry?
The most recently registered devices listed for Arden Medical Systems, Inc. include CHEMPRO 1000(TM), A-QC CLINICAL CHEMISTRY CONTROL and A.QC CHEMISTRY CONTROL LEVEL 2.