Cleared Traditional

ELISA TEST, SEROLOGY

K003794 · Micro Detect, Inc. · Microbiology
Mar 2001
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K003794 is an FDA 510(k) clearance for the ELISA TEST, SEROLOGY, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on March 30, 2001, 112 days after receiving the submission on December 8, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K003794 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2000
Decision Date March 30, 2001
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LYR — Helicobacter Pylori
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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