Cleared Traditional

K802415 - BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT

K802415 is the FDA 510(k) clearance for BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT by Remel Co.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K802415 · Remel Co. · Microbiology device
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Oct 1980
Decision
25d
Days
Class 1
Risk

K802415 is an FDA 510(k) clearance for the BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 25 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 Remel Co. devices

Submission Details

510(k) Number K802415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1980
Decision Date October 31, 1980
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
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 K802415.
PEDIATRIC BLOOD CULTURE BOTTLES
K810553 · Gibco Laboratories Life Technologies, Inc. · Mar 1981
ENRICHED THIOGLYCOLLATE MEDIUM
K803023 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CDC ANAEROBE BLOOD AGAR
K803025 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
ANAEROBE BLOOD AGAR
K802397 · Granite Diagnostics, Inc. · Oct 1980
TODD HEWITT BROTH
K792423 · Isle Media and Sterile Products, Inc. · Jan 1980
TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.
K792594 · Isle Media and Sterile Products, Inc. · Dec 1979