Cleared Traditional

K850718 - CORN MEAL AGAR

K850718 is the FDA 510(k) clearance for CORN MEAL AGAR by Rapid City Regional Hospital, Inc.. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K850718 · Rapid City Regional Hospital, Inc. · Microbiology device
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Mar 1985
Decision
26d
Days
Class 1
Risk

K850718 is an FDA 510(k) clearance for the CORN MEAL AGAR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Rapid City Regional Hospital, Inc. (Rapid City, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 26 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 Rapid City Regional Hospital, Inc. devices

Submission Details

510(k) Number K850718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date March 20, 1985
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
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 - JSH Culture Media, Non-selective And Differential

All 102
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K850718.
BROM CRESOL PURPLE STARCH
K851343 · Micro Media Laboratories · Apr 1985
PURPLE BROTH
K851345 · Micro Media Laboratories · Apr 1985
PHENYLALANINE AGAR
K851346 · Micro Media Laboratories · Apr 1985
V AGAR
K850844 · Micro Media Laboratories · Mar 1985
UREA AGAR
K844548 · bioMerieux, Inc. · Jan 1985
V AGAR
K844513 · bioMerieux, Inc. · Jan 1985