Cleared Traditional

K841659 - DRIGALSKI LITMUS LACTOSE AGAR

K841659 is the FDA 510(k) clearance for DRIGALSKI LITMUS LACTOSE AGAR by Oxoid U.S.A., Inc.. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K841659 · Oxoid U.S.A., Inc. · Microbiology device
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Jun 1984
Decision
45d
Days
Class 1
Risk

K841659 is an FDA 510(k) clearance for the DRIGALSKI LITMUS LACTOSE AGAR. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K841659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date June 07, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 102d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSF Culture Media, Single Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSF Culture Media, Single Biochemical Test

All 57
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K841659.
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K842098 · Austin Biological Laboratories · Jun 1984
RIM SPOT INDOLE
K842097 · Austin Biological Laboratories · Jun 1984
RIM-DNASE KIT
K841389 · Austin Biological Laboratories · May 1984
PORPHYRIN TEST AGAR
K840685 · Remel Co. · Apr 1984