Cleared Traditional

K963376 - MICRO H2

K963376 is an FDA 510(k) clearance for MICRO H2, manufactured by Micro Direct, Inc.. The device is a Class 1 Chemistry device with product code NRH cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K963376 · Micro Direct, Inc. · Chemistry device
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Jan 1997
Decision
150d
Days
Class 1
Risk

K963376 is an FDA 510(k) clearance for the MICRO H2. Classified as System, Breath Measurement (product code NRH), Class I - General Controls.

Submitted by Micro Direct, Inc. (Auburn, US). The FDA issued a Cleared decision on January 24, 1997 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1820 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro Direct, Inc. devices

FDA 510(k) Submission Details - K963376

510(k) Number K963376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date January 24, 1997
Days to Decision 150 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

NRH Device Classification - Class 1, General Controls

Product Code NRH System, Breath Measurement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1820
Definition Breath Measurement Systems Are Used To Measure Constituents Of Exhaled Breath As An Aid In The Diagnosis Of Sugar/nutrient Malabsorbtion And Other Conditions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.