Cleared Special

RAICHEM CREATININE URINE STANDARD

K011126 · Hemagen Diagnostics, Inc. · Chemistry
May 2001
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K011126 is an FDA 510(k) clearance for the RAICHEM CREATININE URINE STANDARD, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on May 2, 2001, 19 days after receiving the submission on April 13, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K011126 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2001
Decision Date May 02, 2001
Days to Decision 19 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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