Cleared Traditional

10B ARGININE BROTH (K961046) - FDA 510(k) Clearance

Class I Microbiology device.

K961046 · Remel, L.P. · Microbiology device
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Sep 1996
Decision
187d
Days
Class 1
Risk

K961046 is an FDA 510(k) clearance for the 10B ARGININE BROTH. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on September 18, 1996 after a review of 187 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Remel, L.P. devices

Submission Details

510(k) Number K961046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1996
Decision Date September 18, 1996
Days to Decision 187 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 102d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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 - JSM Culture Media, Non-propagating Transport

All 110
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