Specialty Medical Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Specialty Medical Industries, Inc. makes
Specialty Medical Industries, Inc. manufactures in vitro diagnostic devices, including protein assay kits for laboratory testing and clinical analyzers for automated biochemical analysis. Their products also include specific IgE assay kits designed for allergen testing.
These devices are regulated under FDA Class I and Class II classifications, with some requiring 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Protein Assay Kit Ref K790808
Regimes: 510(k) Registry: 510(k)Ultrascan Clinical Analyzer Ref K862999
Regimes: 510(k) Registry: 510(k)Ultrascan Ige Assay Kit Ref K872968
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Specialty Medical Industries, Inc. have in the registry?
The registry currently lists 3 devices for Specialty Medical Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Specialty Medical Industries, Inc.'s devices?
Among its 3 most recently registered devices, Specialty Medical Industries, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Specialty Medical Industries, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Specialty Medical Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Specialty Medical Industries, Inc. in the registry?
The most recently registered devices listed for Specialty Medical Industries, Inc. include PROTEIN ASSAY KIT, ULTRASCAN CLINICAL ANALYZER and ULTRASCAN IGE ASSAY KIT.