Cleared Traditional

K974428 - DIPSTREAK

K974428 is an FDA 510(k) clearance for DIPSTREAK, manufactured by Novamed , Ltd.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K974428 · Novamed , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
248d
Days
Class 1
Risk

K974428 is an FDA 510(k) clearance for the DIPSTREAK. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Novamed , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on July 30, 1998 after a review of 248 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 Novamed , Ltd. devices

FDA 510(k) Submission Details - K974428

510(k) Number K974428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date July 30, 1998
Days to Decision 248 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 102d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

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.

Regulatory Peers - JSI Culture Media, Selective And Differential

All 232
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