Cleared Traditional

K870171 - (MERIFLUOR)TM-CRYPTOSPORIDIUM (FDA 510(k) Clearance)

K870171 · Meridian Diagnostics, Inc. · Microbiology device
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Mar 1987
Decision
61d
Days
-
Risk

K870171 is an FDA 510(k) clearance for the (MERIFLUOR)TM-CRYPTOSPORIDIUM.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel. 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 Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K870171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1987
Decision Date March 16, 1987
Days to Decision 61 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 102d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -