Cleared Traditional

K834420 - MANNITOL-SALT AGAR USP PLATE

K834420 is an FDA 510(k) clearance for MANNITOL-SALT AGAR USP PLATE, manufactured by Otisville Biotech, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K834420

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.

JSI Device Classification - Class 1, General Controls

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 232
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