Cleared Traditional

K881535 - ANTIBIOTIC MEDIUM #6

K881535 is the FDA 510(k) clearance for ANTIBIOTIC MEDIUM #6 by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSA) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K881535 · Acumedia Manufacturers, Inc. · Microbiology device
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Apr 1988
Decision
10d
Days
Class 1
Risk

K881535 is an FDA 510(k) clearance for the ANTIBIOTIC MEDIUM #6. Classified as Culture Media, Antibiotic Assay (product code JSA), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2350 - 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 K881535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1988
Decision Date April 18, 1988
Days to Decision 10 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
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSA Culture Media, Antibiotic Assay
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2350
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 - JSA Culture Media, Antibiotic Assay

All 7
Devices cleared under the same product code (JSA) and FDA review panel - the closest regulatory comparables to K881535.
ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR
K881534 · Acumedia Manufacturers, Inc. · Apr 1988
ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR
K881536 · Acumedia Manufacturers, Inc. · Apr 1988
ANTIBIOTIC MEDIUM #19
K881537 · Acumedia Manufacturers, Inc. · Apr 1988
ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR
K881538 · Acumedia Manufacturers, Inc. · Apr 1988
ANTIBIOTIC ASSAY BROTH
K832575 · Acumedia Manufacturers, Inc. · Sep 1983
BASE AGAR
K832576 · Acumedia Manufacturers, Inc. · Sep 1983