Cleared Traditional

K831685 - SF REFEEDING MEDIA

K831685 is the FDA 510(k) clearance for SF REFEEDING MEDIA by Viromed Laboratories, Inc.. It is a Class 1 Pathology device (product code KIT) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K831685 · Viromed Laboratories, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
43d
Days
Class 1
Risk

K831685 is an FDA 510(k) clearance for the SF REFEEDING MEDIA. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Viromed Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2220 - the FDA pathology 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 Viromed Laboratories, Inc. devices

Submission Details

510(k) Number K831685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1983
Decision Date July 06, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 77d · This submission: 43d
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.

Regulatory Peers - KIT Media And Components, Synthetic Cell And Tissue Culture

All 306
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K831685.
DULBECCO'S MODIFIED EAGLE #D5523-
K832688 · Sigma Chemical Co. · Sep 1983
MCCOY'S 5A #M4892 W/L-GLUTAMINE AND
K832689 · Sigma Chemical Co. · Sep 1983
MINIMUM ESSENTIAL MED. EAGLE M0268
K832690 · Sigma Chemical Co. · Sep 1983
BASAL MEDIUM EAGLE W/EARLES SALTS, &
K831745 · Sigma Chemical Co. · Jul 1983
RPMI-1640 MEDIUM W/L-GLUTAMINE &
K831519 · Sigma Chemical Co. · Jun 1983
S-MEM-JOKLIK'S POWDER
K821911 · Dutchland Laboratories, Inc. · Jul 1982