Cleared Special

K003012 - RAICHEM PHOSPORUS REAGENT
(FDA 510(k) Clearance)

K003012 · Hemagen Diagnostics, Inc. · Chemistry

Oct 2000

Decision

29d

Days

Class 1

Risk

K003012 is an FDA 510(k) clearance for the RAICHEM PHOSPORUS REAGENT, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on October 25, 2000, 29 days after receiving the submission on September 26, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number	K003012 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2000
Decision Date	October 25, 2000
Days to Decision	29 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Statement