Elan Pharma, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Elan Pharma, Inc. makes
Elan Pharma, Inc. manufactures reagent kits for clinical chemistry testing, including those for creatinine, urea, cholesterol, and phosphorus measurements. These products are designed for use in laboratory settings to support diagnostic analysis of blood and serum samples.
The company’s reagent kits are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. They are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The company is based in the United States.
Catalogue
Hichem Ck/Nac Reagent Kit Ref K962247
Regimes: 510(k) Registry: 510(k)Hichem Bun/Urea Reagent Kit Ref K960115
Regimes: 510(k) Registry: 510(k)Hichem Cholesterol Reagent Kit Ref K982469
Regimes: 510(k) Registry: 510(k)Hichem Phosphorus Reagent Kit Ref K981769
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elan Pharma, Inc. have in the registry?
The registry currently lists 4 devices for Elan Pharma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elan Pharma, Inc.'s devices?
Among its 4 most recently registered devices, Elan Pharma, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Elan Pharma, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Elan Pharma, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elan Pharma, Inc. in the registry?
The most recently registered devices listed for Elan Pharma, Inc. include HICHEM CK/NAC REAGENT KIT, HICHEM BUN/UREA REAGENT KIT, HICHEM CHOLESTEROL REAGENT KIT and HICHEM PHOSPHORUS REAGENT KIT.