Cleared Traditional

SFP AGAR PLATES (K834424) - FDA 510(k) Clearance

Class I Microbiology device.

K834424 · Otisville Biotech, Inc. · Microbiology device
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Oct 1984
Decision
313d
Days
Class 1
Risk

K834424 is an FDA 510(k) clearance for the SFP AGAR PLATES. 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

Submission Details

510(k) Number K834424 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
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 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 306
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K834424.
GBNA MEDIUM
K871786 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MRS AGAR AND MRS BROTH
K871702 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MCBRIDE AGAR, MODIFIED
K871357 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
ANAEROBIC PEA BLOOD AGAR
K871090 · bioMerieux, Inc. · Apr 1987
BACTEROIDES BILE ESCULIN AGAR
K871091 · bioMerieux, Inc. · Apr 1987
CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
K871093 · bioMerieux, Inc. · Apr 1987