Cleared Traditional

K812531 - CELL CULTURE REAGENTS

K812531 is the FDA 510(k) clearance for CELL CULTURE REAGENTS by M.A. Bioproducts. It is a Class 1 Microbiology device (product code KIT) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K812531 · M.A. Bioproducts · Microbiology device
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Oct 1981
Decision
51d
Days
Class 1
Risk

K812531 is an FDA 510(k) clearance for the CELL CULTURE REAGENTS. Classified as Media And Components, Synthetic Cell And Tissue Culture (product code KIT), Class I - General Controls.

Submitted by M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 51 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 M.A. Bioproducts devices

Submission Details

510(k) Number K812531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1981
Decision Date October 23, 1981
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
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

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