Cleared Traditional

K841212 - SINGLE BIOCHEMICAL TEST

K841212 is the FDA 510(k) clearance for SINGLE BIOCHEMICAL TEST by Smith River Biologicals. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K841212 · Smith River Biologicals · Microbiology device
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Apr 1984
Decision
23d
Days
Class 1
Risk

K841212 is an FDA 510(k) clearance for the SINGLE BIOCHEMICAL TEST. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Smith River Biologicals (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 23 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 Smith River Biologicals devices

Submission Details

510(k) Number K841212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date April 04, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 102d · This submission: 23d
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 59
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K841212.
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
CIN AGAR
K834327 · Hardy Media · Jan 1984
ANDRADES FERMENTATION MEDIA
K822995 · Granite Diagnostics, Inc. · Nov 1982
JORDANS TARTRATE AGAR
K822996 · Granite Diagnostics, Inc. · Nov 1982