Cleared Traditional

K820842 - CULTURE MEDIA

K820842 is the FDA 510(k) clearance for CULTURE MEDIA by Blue Ridge Media Co.. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K820842 · Blue Ridge Media Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
21d
Days
Class 1
Risk

K820842 is an FDA 510(k) clearance for the CULTURE MEDIA, NON-SELECTIVE/DIFFER. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Blue Ridge Media Co. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1982 after a review of 21 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 Blue Ridge Media Co. devices

Submission Details

510(k) Number K820842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1982
Decision Date April 16, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSE Culture Media, Multiple 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 - JSE Culture Media, Multiple Biochemical Test

All 39
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K820842.
CHRISTENSENS CITRATE SULFIDE AGAR
K822998 · Granite Diagnostics, Inc. · Nov 1982
LECITHIN LACTOSE AGAR
K823072 · Granite Diagnostics, Inc. · Nov 1982
TRIPLE SUGAR IRON AGAR SLANT
K821592 · Hardy Media · Jul 1982
BCYE MEDIUM
K812911 · Gibco Laboratories Life Technologies, Inc. · Nov 1981
RAPID FERMENTATION AGAR (RFA)
K800734 · Remel Co. · May 1980
SIM MEDIUM
K792420 · Isle Media and Sterile Products, Inc. · Dec 1979