Cleared Traditional

K843085 - RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA (FDA 510(k) Clearance)

Class I Microbiology device.

K843085 · Sigma Chemical Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
22d
Days
Class 1
Risk

K843085 is an FDA 510(k) clearance for the RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2220 - 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K843085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date August 28, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIT Media And Components, Synthetic Cell And Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2220
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.