American Bioclinical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What American Bioclinical, Inc. makes
American Bioclinical, Inc. manufactures diagnostic test systems for hormone and pregnancy marker detection, including radioimmunoassay (RIA) and enzyme immunoassay (EIA) kits for prolactin, cortisol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and human chorionic gonadotropin (HCG) in serum and urine. Their products are designed for laboratory use to quantify hormone levels and confirm pregnancy status.
The company’s diagnostic systems are classified as Class I and Class II devices under FDA regulations, with some products requiring 510(k) clearance. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Prolactin System By Ria Ref K851330
510(k) 510(k)Cortisol System By Eia Ref K852939
510(k) 510(k)Visual Serum/Urine Hcg Combo Kit Ref K852437
510(k) 510(k)Simultaneous Lh/Fsh System By Ria Ref K852376
510(k) 510(k)
Frequently asked questions
How many devices does American Bioclinical, Inc. have in the registry?
The registry currently lists 4 devices for American Bioclinical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Bioclinical, Inc.'s devices?
Among its 4 most recently registered devices, American Bioclinical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do American Bioclinical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for American Bioclinical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Bioclinical, Inc. in the registry?
The most recently registered devices listed for American Bioclinical, Inc. include PROLACTIN SYSTEM BY RIA, CORTISOL SYSTEM BY EIA, VISUAL SERUM/URINE HCG COMBO KIT and SIMULTANEOUS LH/FSH SYSTEM BY RIA.