Cleared Traditional

K872904 - BINAX EQUATE STREP B

K872904 is the FDA 510(k) clearance for BINAX EQUATE STREP B by Binax, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K872904 · Binax, Inc. · Microbiology device
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Nov 1987
Decision
119d
Days
Class 1
Risk

K872904 is an FDA 510(k) clearance for the BINAX EQUATE STREP B. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Binax, Inc. (S. Portland, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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 Binax, Inc. devices

Submission Details

510(k) Number K872904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1987
Decision Date November 20, 1987
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 102d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 56
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