Cleared Traditional

K820509 - MEM VITAMINS (100X

K820509 is an FDA 510(k) clearance for MEM VITAMINS (100X, manufactured by Dutchland Laboratories, Inc.. The device is a Class 1 Chemistry device with product code KIT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K820509 · Dutchland Laboratories, Inc. · Chemistry device
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Apr 1982
Decision
44d
Days
Class 1
Risk

K820509 is an FDA 510(k) clearance for the MEM VITAMINS (100X. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1982 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.2220 - the FDA in vitro diagnostics and chemistry 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 Dutchland Laboratories, Inc. devices

FDA 510(k) Submission Details - K820509

510(k) Number K820509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1982
Decision Date April 08, 1982
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

KIT Device Classification - Class 1, General Controls

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 335
Devices cleared under the same product code (KIT) and FDA review panel - the closest regulatory comparables to K820509.
RPMI-164POWDERED MEDIUM
K820929 · Dutchland Laboratories, Inc. · Apr 1982
FISCHER'S POWDERED MEDIUM
K820930 · Dutchland Laboratories, Inc. · Apr 1982
HANK'S 199 POWDERED MEDIUM
K820931 · Dutchland Laboratories, Inc. · Apr 1982
SODIUM PYRUVATE (100MM)
K820495 · Dutchland Laboratories, Inc. · Mar 1982
MEM NON-ESSENTIAL AMINO ACIDS (100X)
K820508 · Dutchland Laboratories, Inc. · Mar 1982
DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM
K812885 · Dutchland Laboratories, Inc. · Nov 1981