Cleared Traditional

SENSI-CAL AMCO AEPA-1

K935566 · Radiometer America, Inc. · Microbiology
Mar 1994
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K935566 is an FDA 510(k) clearance for the SENSI-CAL AMCO AEPA-1, a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on March 29, 1994, 131 days after receiving the submission on November 18, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K935566 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1993
Decision Date March 29, 1994
Days to Decision 131 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LIE — Reagent/device, Inoculum Calibration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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