Cleared Traditional

K971637 - COMPOUND SULPHONAMIDES ANTIMICROBIAL SU...

K971637 is the FDA 510(k) clearance for COMPOUND SULPHONAMIDES ANTIMICROBIAL SU... by Oxoid , Ltd.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K971637 · Oxoid , Ltd. · Microbiology device
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Dec 1997
Decision
235d
Days
Class 2
Risk

K971637 is an FDA 510(k) clearance for the COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on December 23, 1997 after a review of 235 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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. Standard predicate reliance. 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 Oxoid , Ltd. devices

Submission Details

510(k) Number K971637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date December 23, 1997
Days to Decision 235 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 102d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K971637.
PASCO MIC AND MIC/ID PANELS
K980955 · Pasco Laboratories, Inc. · May 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · Oxoid , Ltd. · Jan 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · Oxoid , Ltd. · Jan 1998
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · Oxoid , Ltd. · Dec 1997
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973488 · Oxoid , Ltd. · Oct 1997
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973489 · Oxoid , Ltd. · Oct 1997