Cleared Traditional

K820844 - CULTURE MEDIA, SELECTIVE & DIFFERENTIAL

K820844 is an FDA 510(k) clearance for CULTURE MEDIA, manufactured by Blue Ridge Media Co.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K820844 · 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

K820844 is an FDA 510(k) clearance for the CULTURE MEDIA, SELECTIVE & DIFFERENTIAL. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Blue Ridge Media Co. (Walker, 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 866.2360 - 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 Blue Ridge Media Co. devices

FDA 510(k) Submission Details - K820844

510(k) Number K820844 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.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And 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 - JSI Culture Media, Selective And Differential

All 233
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K820844.
#2010 CAMPHYLOBACTER AGAR
K821300 · Biomedia, Inc. · Jun 1982
#50002 QUAD DIAGNOSTIC SYSTEM
K821301 · Biomedia, Inc. · Jun 1982
BI PLATE-XLD/HEKTOEN #30012
K821108 · Biomedia, Inc. · May 1982
#50001 QUADE DIAGNOSTIC SYSTEM
K820797 · Biomedica, Inc. · Apr 1982
#2001 HEKTOEN
K820798 · Biomedica, Inc. · Apr 1982
#2006 SALMONELLA SHIGELLA AGAR
K820800 · Biomedica, Inc. · Apr 1982