Cleared Traditional

K920416 - SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB

K920416 is the FDA 510(k) clearance for SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB by Behring Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LIB) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K920416 · Behring Diagnostics, Inc. · Microbiology device
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Apr 1992
Decision
68d
Days
Class 1
Risk

K920416 is an FDA 510(k) clearance for the SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K920416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date April 08, 1992
Days to Decision 68 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
34d faster than avg
Panel avg: 102d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 13
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