Cleared Traditional

K830525 - API 20GP

K830525 is an FDA 510(k) clearance for API 20GP, manufactured by Analytical Products, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K830525

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

JSE Device Classification - Class 1, General Controls

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 43
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K830525.
MYCOBIOTIC AGAR
K834004 · Micro Media Laboratories · Dec 1983
SIM MEDIUM
K834012 · Micro Media Laboratories · Dec 1983
INDOLE NITRATE MEDIUM
K832568 · Acumedia Manufacturers, Inc. · Sep 1983
CHRISTENSENS CITRATE SULFIDE AGAR
K822998 · Granite Diagnostics, Inc. · Nov 1982
LECITHIN LACTOSE AGAR
K823072 · Granite Diagnostics, Inc. · Nov 1982
TRIPLE SUGAR IRON AGAR SLANT
K821592 · Hardy Media · Jul 1982