Cleared Traditional

MACCONKEY'S AGAR PLATE (K832934) - FDA 510(k) Clearance

K832934 · Otisville Biotech, Inc. · Microbiology device
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Sep 1983
Decision
30d
Days
-
Risk

K832934 is an FDA 510(k) clearance for the MACCONKEY'S AGAR PLATE.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 30 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K832934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1983
Decision Date September 29, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -