Cleared Traditional

K832568 - INDOLE NITRATE MEDIUM

K832568 is the FDA 510(k) clearance for INDOLE NITRATE MEDIUM by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K832568 · Acumedia Manufacturers, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1983
Decision
41d
Days
Class 1
Risk

K832568 is an FDA 510(k) clearance for the INDOLE NITRATE MEDIUM. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 41 days - a notably fast clearance cycle.

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: 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K832568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date September 12, 1983
Days to Decision 41 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
61d faster than avg
Panel avg: 102d · This submission: 41d
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 38
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K832568.
MOTILITY INDOLE ORNITHINE-MEDIUM
K834003 · Micro Media Laboratories · Dec 1983
MYCOBIOTIC AGAR
K834004 · Micro Media Laboratories · Dec 1983
SIM MEDIUM
K834012 · Micro Media Laboratories · Dec 1983
API 20GP
K830525 · Analytical Products, Inc. · May 1983
CHRISTENSENS CITRATE SULFIDE AGAR
K822998 · Granite Diagnostics, Inc. · Nov 1982
LECITHIN LACTOSE AGAR
K823072 · Granite Diagnostics, Inc. · Nov 1982