Cleared Traditional

K830525 - API 20GP

K830525 is the FDA 510(k) clearance for API 20GP by Analytical Products, Inc.. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K830525 · Analytical Products, Inc. · Microbiology device
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May 1983
Decision
90d
Days
Class 1
Risk

K830525 is an FDA 510(k) clearance for the API 20GP. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1983 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Analytical Products, Inc. devices

Submission Details

510(k) Number K830525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1983
Decision Date May 18, 1983
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSE Culture Media, Multiple 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 - JSE Culture Media, Multiple Biochemical Test

All 22
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K830525.
BIOTIS KLIGLER IRON AGAR
K843768 · Otisville Biotech, Inc. · Oct 1984
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424 · Otisville Biotech, Inc. · Jul 1984
INDOLE NITRATE MEDIUM
K832568 · Acumedia Manufacturers, Inc. · Sep 1983
TRIPLE SUGAR IRON AGAR SLANT
K821592 · Hardy Media · Jul 1982
BCYE MEDIUM
K812911 · Gibco Laboratories Life Technologies, Inc. · Nov 1981
RAPID FERMENTATION AGAR (RFA)
K800734 · Remel Co. · May 1980