Cleared Traditional

THIOGLYCOLLATE MED. W/OUT INDICATOR (K811515) - FDA 510(k) Clearance

Class I Toxicology device.

K811515 · Oxoid U.S.A., Inc. · Toxicology device
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Jun 1981
Decision
27d
Days
Class 1
Risk

K811515 is an FDA 510(k) clearance for the THIOGLYCOLLATE MED. W/OUT INDICATOR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2300 - the FDA toxicology 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 K811515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1981
Decision Date June 24, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 208
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K811515.
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
K881115 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
ANAEROBIC BLOOD AGAR (CDC FORMULATION)
K871089 · bioMerieux, Inc. · Apr 1987
TRYPTIC SOY AGAR
K871098 · bioMerieux, Inc. · Apr 1987
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · Roche Diagnostic Systems, Inc. · Apr 1985
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR
K844526 · bioMerieux, Inc. · Jan 1985
NUTRIENT BROTH
K844528 · bioMerieux, Inc. · Jan 1985