Cleared Traditional

BIOTIS N.Y.C. CARBOHYDRATE FERMENTA- (K842400) - FDA 510(k) Clearance

K842400 · Otisville Biotech, Inc. · Microbiology device
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Jul 1984
Decision
13d
Days
-
Risk

K842400 is an FDA 510(k) clearance for the BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1984 after a review of 13 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 K842400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date July 02, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -