Cleared Traditional

K880106 - ACETAMIDE AGAR SLANT

K880106 is the FDA 510(k) clearance for ACETAMIDE AGAR SLANT by Hardy Media. It is a Class 1 Microbiology device (product code JSF) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K880106 · Hardy Media · Microbiology device
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Mar 1988
Decision
84d
Days
Class 1
Risk

K880106 is an FDA 510(k) clearance for the ACETAMIDE AGAR SLANT. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 30, 1988 after a review of 84 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 Hardy Media devices

Submission Details

510(k) Number K880106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date March 30, 1988
Days to Decision 84 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
18d faster than avg
Panel avg: 102d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSF Culture Media, Single 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 - JSF Culture Media, Single Biochemical Test

All 57
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K880106.
MOELLERS DECARBOXYLASE, ONITHINE
K880119 · Hardy Media · Mar 1988
MOELLERS DECARBOXYLASE, LYSINE
K880120 · Hardy Media · Mar 1988
LAURYL TRYPTOSE BROTH
K880126 · Hardy Media · Mar 1988
CYSTINE TRYPTIC MEDIUM W/DEXTROSE
K880110 · Hardy Media · Mar 1988
CYSTINE TRYPTIC MEDIUM W/SUCROSE
K880111 · Hardy Media · Mar 1988
CYSTINE TRYPTIC MEDIUM W/ MALTOSE
K880112 · Hardy Media · Mar 1988