Cleared Traditional

K880142 - TSA W/LEC. & TWEEN. 80

K880142 is the FDA 510(k) clearance for TSA W/LEC. & TWEEN. 80 by Hardy Media. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K880142 · Hardy Media · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
84d
Days
Class 1
Risk

K880142 is an FDA 510(k) clearance for the TSA W/LEC. & TWEEN. 80. Classified as Culture Media, Non-selective And Non-differential (product code JSG), 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 866.2300 - 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 K880142 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 JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K880142.
TRYPTOSE PHOSPHATE BROTH
K881563 · Acumedia Manufacturers, Inc. · Apr 1988
TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT
K881564 · Acumedia Manufacturers, Inc. · Apr 1988
NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE
K880947 · Lakewood Biochemical Co., Inc. · Apr 1988
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
K881115 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1988
NUTRIENT BROTH
K880114 · Hardy Media · Mar 1988
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750
K875136 · Lakewood Biochemical Co., Inc. · Jan 1988