Cleared Traditional

K834419 - COLUMBIA CNA AGAR PLATE

K834419 is an FDA 510(k) clearance for COLUMBIA CNA AGAR PLATE, manufactured by Otisville Biotech, Inc.. The device is a Class 1 Microbiology device with product code JSJ cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K834419 · Otisville Biotech, Inc. · Microbiology device
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Oct 1984
Decision
313d
Days
Class 1
Risk

K834419 is an FDA 510(k) clearance for the COLUMBIA CNA AGAR PLATE. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Otisville Biotech, Inc. (Walker, US). The FDA issued a Cleared decision on October 23, 1984 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Otisville Biotech, Inc. devices

FDA 510(k) Submission Details - K834419

510(k) Number K834419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1983
Decision Date October 23, 1984
Days to Decision 313 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 102d · This submission: 313d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 271
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K834419.
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