Cleared Traditional

K880124 - LOWENSTEIN-JENSEN

K880124 is the FDA 510(k) clearance for LOWENSTEIN-JENSEN by Hardy Media. It is a Class 1 Microbiology device (product code JSJ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K880124 · Hardy Media · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
85d
Days
Class 1
Risk

K880124 is an FDA 510(k) clearance for the LOWENSTEIN-JENSEN, W/NACL. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 31, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 K880124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1988
Decision Date March 31, 1988
Days to Decision 85 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
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 239
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K880124.
W-L DIFFERENTIAL MEDIUM
K881574 · Acumedia Manufacturers, Inc. · Apr 1988
STREPTOSEL
K881578 · Acumedia Manufacturers, Inc. · Apr 1988
LOWENSTEIN-JENSEN SLANT
K880123 · Hardy Media · Mar 1988
SABOURAUD DEXTROSE AGAR W/CHLORO
K880128 · Hardy Media · Mar 1988
CETRIMIDE SELECTIVE AGAR
K880136 · Hardy Media · Mar 1988
BHI WITH C & C SLANT
K880137 · Hardy Media · Mar 1988