Cleared Traditional

K070691 - BBL CHROMAGAR 0157 (FDA 510(k) Clearance)

Class I Microbiology device.

K070691 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
252d
Days
Class 1
Risk

K070691 is an FDA 510(k) clearance for the BBL CHROMAGAR 0157. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 252 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Becton, Dickinson & CO devices

Submission Details

510(k) Number K070691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date November 20, 2007
Days to Decision 252 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 102d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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.