Cleared Traditional

K090967 - BD MULTITEST 6-COLOR TBNK REAGENT

K090967 is the FDA 510(k) clearance for BD MULTITEST 6-COLOR TBNK REAGENT by Bd Biosciences. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K090967 · Bd Biosciences · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
116d
Days
Class 2
Risk

K090967 is an FDA 510(k) clearance for the BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Biosciences (San Jose, US). The FDA issued a Cleared decision on July 31, 2009 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Biosciences devices

Submission Details

510(k) Number K090967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date July 31, 2009
Days to Decision 116 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 113d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K090967.
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