Cytocolor, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Cytocolor, Inc. makes
Cytocolor, Inc. manufactures manual hematology staining reagents, including LYSOCOLOR for lymphocyte staining, GRANULOCOLOR for granulocyte differentiation, MEGACOLOR for megakaryocyte identification, NEUTROCOLOR for neutrophil staining, and PANOPTIKON for general blood smear staining. These products are designed for use in manual microscopic examination of blood and bone marrow samples in clinical laboratories.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These reagents are intended for use in the United States, where the company is based.
Catalogue
Lysocolor Ref K860321
510(k) 510(k)Granulocolor Ref K860320
510(k) 510(k)Megacolor Ref K860319
510(k) 510(k)Neutrocolor Ref K860317
510(k) 510(k)Panoptikon Ref K860316
510(k) 510(k)
Frequently asked questions
How many devices does Cytocolor, Inc. have in the registry?
The registry currently lists 5 devices for Cytocolor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cytocolor, Inc.'s devices?
Among its 5 most recently registered devices, Cytocolor, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Cytocolor, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Cytocolor, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cytocolor, Inc. in the registry?
The most recently registered devices listed for Cytocolor, Inc. include LYSOCOLOR, GRANULOCOLOR, MEGACOLOR and NEUTROCOLOR.