Cleared Traditional

K880139 - ONPG TEST REAGENT

K880139 is the FDA 510(k) clearance for ONPG TEST REAGENT 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.

K880139 · Hardy Media · Microbiology device
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Mar 1988
Decision
84d
Days
Class 1
Risk

K880139 is an FDA 510(k) clearance for the ONPG TEST REAGENT. 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 K880139 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 K880139.
MOELLOERS DECARBOXYLASE, ARGININE
K880118 · Hardy Media · Mar 1988
BRILLIANT GREEN BILE BROTH
K880129 · Hardy Media · Mar 1988
NITRATE BROTH
K880135 · Hardy Media · Mar 1988
NUTRIENT GELATIN
K880115 · Hardy Media · Mar 1988
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
K873828 · Lakewood Biochemical Co., Inc. · Oct 1987
TRYPTONE BROTH, 2%
K870641 · Hardy Media · Apr 1987