Cleared Traditional

RAPID READER

K041696 · American Bio Medica Corp. · Chemistry
Jul 2005
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K041696 is an FDA 510(k) clearance for the RAPID READER, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by American Bio Medica Corp. (Beverly, US). The FDA issued a Cleared decision on July 12, 2005, 385 days after receiving the submission on June 22, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K041696 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2004
Decision Date July 12, 2005
Days to Decision 385 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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