Cleared Traditional

ANALYST PANELS + ANALYTICAL TEST ROTOR

K010864 · Hemagen Diagnostics, Inc. · Chemistry
May 2001
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K010864 is an FDA 510(k) clearance for the ANALYST PANELS + ANALYTICAL TEST ROTOR, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on May 21, 2001, 60 days after receiving the submission on March 22, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K010864 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2001
Decision Date May 21, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHS — Enzymatic, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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