Cleared Traditional

K850738 - SUPPLEMENT FOR CULTURE MEDIUM (FDA 510(k) Clearance)

Class I Microbiology device.

K850738 · Roseville Medical Laboratoriesu · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
28d
Days
Class 1
Risk

K850738 is an FDA 510(k) clearance for the SUPPLEMENT FOR CULTURE MEDIUM. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Roseville Medical Laboratoriesu (Roseville, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - 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 Roseville Medical Laboratoriesu devices

Submission Details

510(k) Number K850738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1985
Decision Date March 20, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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.