Scientific Distributors, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Scientific Distributors, Inc. makes
Scientific Distributors, Inc. manufactures preparation and dilution kits for hematology testing, including the PREPAX DILUKIT PLUS and variants like the CT, HW, and CA models. These kits are designed for use in blood cell counting and dilution procedures, ensuring precise sample preparation for laboratory analysis. Additional offerings include the COUNTAPETTE KIT, which supports automated hematology workflows.
The company’s products are classified under Class I medical devices in the U.S. and are listed via 510(k) clearance with the FDA. The portfolio is regulated under U.S. jurisdiction, with no additional international registries or classifications specified.
Catalogue
Prepax Dilukit Plus Ref K840038
Regimes: 510(k) Registry: 510(k)Sdi Prepax Dilukit Ct Ref K840043
Regimes: 510(k) Registry: 510(k)Sdi Prepax Dilukit Hw Ref K840041
Regimes: 510(k) Registry: 510(k)Sdi Prepax Countapette Kit Ref K892658
Regimes: 510(k) Registry: 510(k)Sdi Prepax Dilukit M. Ref K851320
Regimes: 510(k) Registry: 510(k)Sdi Prepax Dilukit 29-1000 Ref K840044
Regimes: 510(k) Registry: 510(k)Sdi Prepax Dilukit Ca Ref K840042
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scientific Distributors, Inc. have in the registry?
The registry currently lists 7 devices for Scientific Distributors, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scientific Distributors, Inc.'s devices?
Among its 7 most recently registered devices, Scientific Distributors, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Scientific Distributors, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Scientific Distributors, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Scientific Distributors, Inc. in the registry?
The most recently registered devices listed for Scientific Distributors, Inc. include PREPAX DILUKIT PLUS, SDI PREPAX DILUKIT CT, SDI PREPAX DILUKIT HW and SDI PREPAX COUNTAPETTE KIT.