Cleared Traditional

CULTURIA MACCONKEY/CLED #DM87 (K800215) - FDA 510(k) Clearance

Class I Microbiology device.

K800215 · Clinical Convenience Products, Inc. · Microbiology device
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Feb 1980
Decision
9d
Days
Class 1
Risk

K800215 is an FDA 510(k) clearance for the CULTURIA MACCONKEY/CLED #DM87. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Clinical Convenience Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Clinical Convenience Products, Inc. devices

Submission Details

510(k) Number K800215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1980
Decision Date February 13, 1980
Days to Decision 9 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 102d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.