Cleared Traditional

K880107 - CAMPY BROTH

K880107 is the FDA 510(k) clearance for CAMPY BROTH by Hardy Media. It is a Class 1 Microbiology device (product code JSD) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K880107 · Hardy Media · Microbiology device
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Mar 1988
Decision
84d
Days
Class 1
Risk

K880107 is an FDA 510(k) clearance for the CAMPY BROTH. Classified as Culture Media, Selective Broth (product code JSD), 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 866.2360 - 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 K880107 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 JSD Culture Media, Selective Broth
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 - JSD Culture Media, Selective Broth

All 20
Devices cleared under the same product code (JSD) and FDA review panel - the closest regulatory comparables to K880107.
FASTIDIOUS INOCULUM BROTH
K883075 · Baxter Healthcare Corp · Aug 1988
SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331
K873324 · Lakewood Biochemical Co., Inc. · Oct 1987
BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
K873218 · Lakewood Biochemical Co., Inc. · Sep 1987
TODD HEWITT W/CNA (LIM BROTH)
K871447 · Remel Co. · May 1987
ALKALINE PEPTONE WATER
K871640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
T9802 TSB W/6.5% NACL
K870594 · Lakewood Biochemical Co., Inc. · Mar 1987