Cleared Traditional

K820563 - THIOGLYCOLLATE ENRICHED

K820563 is the FDA 510(k) clearance for THIOGLYCOLLATE ENRICHED by American Laboratory Supply, Inc.. It is a Class 1 Chemistry device (product code KZI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K820563 · American Laboratory Supply, Inc. · Chemistry device
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Mar 1982
Decision
14d
Days
Class 1
Risk

K820563 is an FDA 510(k) clearance for the THIOGLYCOLLATE ENRICHED. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by American Laboratory Supply, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1982 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2330 - the FDA in vitro diagnostics and chemistry 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 American Laboratory Supply, Inc. devices

Submission Details

510(k) Number K820563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date March 16, 1982
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
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: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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.