Shandon, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Shandon, Inc. makes
Shandon, Inc. manufactures laboratory reagents and staining solutions, including coverslippers for slide preparation, and instant staining kits such as Linistain SLS, Instant Eosin-Aqueous, Instant Hematoxylin, and Instant Eosin-Alcoholic for histological and cytological applications.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Coverslipper Ref K780261
Regimes: 510(k) Registry: 510(k)Linistain Sls Ref K890984
Regimes: 510(k) Registry: 510(k)Instant Eosin-Aqueous Ref K893663
Regimes: 510(k) Registry: 510(k)Instant Hematoxylin Ref K873107
Regimes: 510(k) Registry: 510(k)Instant Eosin-Alcoholic Ref K880240
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Shandon, Inc. have in the registry?
The registry currently lists 5 devices for Shandon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandon, Inc.'s devices?
Among its 5 most recently registered devices, Shandon, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Shandon, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Shandon, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Shandon, Inc. in the registry?
The most recently registered devices listed for Shandon, Inc. include COVERSLIPPER, LINISTAIN SLS, INSTANT EOSIN-AQUEOUS and INSTANT HEMATOXYLIN.