Cleared Traditional

K834420 - MANNITOL-SALT AGAR USP PLATE

K834420 is the FDA 510(k) clearance for MANNITOL-SALT AGAR USP PLATE by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSI) cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K834420 · Otisville Biotech, Inc. · Microbiology device
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Oct 1984
Decision
313d
Days
Class 1
Risk

K834420 is an FDA 510(k) clearance for the MANNITOL-SALT AGAR USP PLATE. Classified as Culture Media, Selective And Differential (product code JSI), 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

Submission Details

510(k) Number K834420 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.

Device Classification

Product Code JSI Culture Media, Selective And 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 - JSI Culture Media, Selective And Differential

All 187
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K834420.
VIOLET RED BILE AGAR
K844515 · bioMerieux, Inc. · Jan 1985
YERSINIA SELECTIVE AGAR
K844535 · bioMerieux, Inc. · Jan 1985
BIOTIS ANAEROBIC KBE AGAR
K844195 · Otisville Biotech, Inc. · Nov 1984
S S AGAR PLATE
K834423 · Otisville Biotech, Inc. · Oct 1984
BIOTIS BIGGY AGAR & BIGGY SLANT
K843761 · Otisville Biotech, Inc. · Oct 1984
BIOTIS EMB-LEVINE AGAR
K843762 · Otisville Biotech, Inc. · Oct 1984