Cleared Traditional

K961046 - 10B ARGININE BROTH

K961046 is an FDA 510(k) clearance for 10B ARGININE BROTH, manufactured by Remel, L.P.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 187-day FDA review.

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

FDA 510(k) Submission Details - K961046

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.

JSM Device Classification - Class 1, General Controls

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 59
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K961046.
A.C.T. IV
K965150 · Remel Co. · Jan 1997
A.C.T. III
K965151 · Remel Co. · Jan 1997
A.C.T. II
K965152 · Remel Co. · Jan 1997
CVM TRANSPORT
K955451 · Hardy Diagnostics · Jul 1996
FLEXTRANS
K935987 · Baxter Diagnostics, Inc. · Aug 1994
AEROBIC FOAM SWAB CULTURETTE(R)
K913789 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991