Cleared Abbreviated

K010877: CHEMWELL, MODEL 2900

K010877 · Awareness Technology, Inc. · Chemistry
May 2001
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K010877 is an FDA 510(k) clearance for the CHEMWELL, MODEL 2900, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on May 23, 2001, 61 days after receiving the submission on March 23, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K010877 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2001
Decision Date May 23, 2001
Days to Decision 61 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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