Cleared Traditional

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

K022660 · Biocheck, Inc. · Chemistry
Dec 2002
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K022660 is an FDA 510(k) clearance for the BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117, a Amplifier And Signal Conditioner, Biopotential (Class II — Special Controls, product code DRR), submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on December 19, 2002, 132 days after receiving the submission on August 9, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 870.2050.

Submission Details

510(k) Number K022660 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2002
Decision Date December 19, 2002
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DRR — Amplifier And Signal Conditioner, Biopotential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2050

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