Cleared Traditional

K935566 - SENSI-CAL AMCO AEPA-1

K935566 is an FDA 510(k) clearance for SENSI-CAL AMCO AEPA-1, manufactured by Radiometer America, Inc.. The device is a Class 2 Microbiology device with product code LIE cleared through the Traditional 510(k) pathway after a 131-day FDA review.

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

K935566 is an FDA 510(k) clearance for the SENSI-CAL AMCO AEPA-1. Classified as Reagent/device, Inoculum Calibration (product code LIE), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiometer America, Inc. devices

FDA 510(k) Submission Details - K935566

510(k) Number K935566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 102d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIE Device Classification - Class 2, Special Controls

Product Code LIE Reagent/device, Inoculum Calibration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LIE Reagent/device, Inoculum Calibration

Devices cleared under the same product code (LIE) and FDA review panel - the closest regulatory comparables to K935566.
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TURBIDOMETRIC STANDARD
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DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · Difco Laboratories, Inc. · Feb 1989
PROMPT INOCULATION SYSTEM
K820299 · 3M Company · Mar 1982