Cleared Traditional

K844288 - INRA MENEZO B2 MEDIA

K844288 is an FDA 510(k) clearance for INRA MENEZO B2 MEDIA, manufactured by Fcs Laboratories, Inc.. The device is a Class 1 Hematology device with product code KIT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K844288 · Fcs Laboratories, Inc. · Hematology device
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Dec 1984
Decision
38d
Days
Class 1
Risk

K844288 is an FDA 510(k) clearance for the INRA MENEZO B2 MEDIA. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by Fcs Laboratories, Inc. (Whitehouse, US). The FDA issued a Cleared decision on December 13, 1984 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.2220 - the FDA hematology 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.

FDA 510(k) Submission Details - K844288

510(k) Number K844288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1984
Decision Date December 13, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 113d · This submission: 38d
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 359
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K844288 · INRA MENEZO B2 MEDIA
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