Eppendorf-Brinkmann, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Eppendorf-Brinkmann, Inc. makes
Eppendorf-Brinkmann, Inc. produces diagnostic test kits for laboratory use, including the Glycohemoglobin-SKREEN Test Kit for measuring hemoglobin A1c levels and urinary screening tests for 17-ketosteroids, 17-hydroxycorticosteroids, and vanillylmandelic acid (VMA). These products are designed for clinical chemistry and endocrinology applications, aiding in the detection and monitoring of metabolic and hormonal conditions.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution in the United States.
Catalogue
Glycohemoglobin-Skreen Test Kit Ref K780819
510(k) 510(k)Urinary 17-Ketosteriod/17 Ref K772337
510(k) 510(k)Urin. L7-Oh Corticosteroid T(Non Hydro) Ref K761271
510(k) 510(k)Urinary Vma - Screen Test Kit Ref K772151
510(k) 510(k)
Frequently asked questions
How many devices does Eppendorf-Brinkmann, Inc. have in the registry?
The registry currently lists 4 devices for Eppendorf-Brinkmann, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eppendorf-Brinkmann, Inc.'s devices?
Among its 4 most recently registered devices, Eppendorf-Brinkmann, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Eppendorf-Brinkmann, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Eppendorf-Brinkmann, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Eppendorf-Brinkmann, Inc. in the registry?
The most recently registered devices listed for Eppendorf-Brinkmann, Inc. include GLYCOHEMOGLOBIN-SKREEN TEST KIT, URINARY 17-KETOSTERIOD/17, URIN. L7-OH CORTICOSTEROID T(NON HYDRO) and URINARY VMA - SCREEN TEST KIT.