Cleared Traditional

K831219 - CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE

K831219 is the FDA 510(k) clearance for CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE by Gibco Laboratories Life Technologies, Inc.. It is a Class 1 Microbiology device (product code JSK) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K831219 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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May 1983
Decision
28d
Days
Class 1
Risk

K831219 is an FDA 510(k) clearance for the CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - 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 Gibco Laboratories Life Technologies, Inc. devices

Submission Details

510(k) Number K831219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date May 13, 1983
Days to Decision 28 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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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 - JSK Supplement, Culture Media

All 56
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K831219.
CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER
K833020 · Gibco Laboratories Life Technologies, Inc. · Oct 1983
MIDDLEBROOK ADC ENRICHMENT
K832902 · Gibco Laboratories Life Technologies, Inc. · Sep 1983
LEGIONELLA CYE AGAR BASE & BCYE SUPPL
K831469 · Oxoid U.S.A., Inc. · Jun 1983
YEAST AUTOLYXATE SUPPLEMENT
K822458 · Oxoid U.S.A., Inc. · Sep 1982
VCAT ANTIBIOTIC SUPPLEMENT
K822459 · Oxoid U.S.A., Inc. · Sep 1982
LCAT ANTIBIOTIC SUPPLEMENT
K822460 · Oxoid U.S.A., Inc. · Sep 1982