Jasins & Sayles Associates, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Jasins & Sayles Associates, Inc. makes
Jasins & Sayles Associates, Inc. manufactures lysing reagents and isotonic blood cell diluents, which are used in hematological testing to prepare blood samples for analysis. These products facilitate the breakdown of red blood cells and other components to enable accurate hemoglobin measurement and cell counting in laboratory settings.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the 510(k) premarket notification database. These devices are intended for general use in clinical laboratories and are subject to the standard controls applicable to Class I devices.
Catalogue
Lysing & Hemoglobin S-Reagent J & S Ref K833444
Regimes: 510(k) Registry: 510(k)Isotonic Blood Cell Diluent J & S Ref K833443
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Jasins & Sayles Associates, Inc. have in the registry?
The registry currently lists 2 devices for Jasins & Sayles Associates, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jasins & Sayles Associates, Inc.'s devices?
Among its 2 most recently registered devices, Jasins & Sayles Associates, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Jasins & Sayles Associates, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Jasins & Sayles Associates, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Jasins & Sayles Associates, Inc. in the registry?
The most recently registered devices listed for Jasins & Sayles Associates, Inc. include LYSING & HEMOGLOBIN S-REAGENT J & S and ISOTONIC BLOOD CELL DILUENT J & S.