RAICHEM PHOSPORUS REAGENT— 510(k) K003012

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K003012 for RAICHEM PHOSPORUS REAGENT, Substantially Equivalent on 2000-10-25. Applicant: Hemagen Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant
Hemagen Diagnostics, Inc.
Product code
Code CEO
Device class
Class 1
Regulation
21 CFR 862.1580
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Columbia, MD, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CEO

view all

More clearances from Hemagen Diagnostics, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.