Cleared Traditional

K892730 - IFA SENSIBAC CHLROAMPHENICOL

K892730 is an FDA 510(k) clearance for IFA SENSIBAC CHLROAMPHENICOL, manufactured by Investigacion Farmaceutica S.A. DE C.V.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K892730 · Investigacion Farmaceutica S.A. DE C.V. · Microbiology device
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Aug 1989
Decision
111d
Days
Class 2
Risk

K892730 is an FDA 510(k) clearance for the IFA SENSIBAC CHLROAMPHENICOL. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Investigacion Farmaceutica S.A. DE C.V. (Mexico, MX). The FDA issued a Cleared decision on August 3, 1989 after a review of 111 days - within the typical 510(k) review window.

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 Investigacion Farmaceutica S.A. DE C.V. devices

FDA 510(k) Submission Details - K892730

510(k) Number K892730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1989
Decision Date August 03, 1989
Days to Decision 111 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
9d slower than avg
Panel avg: 102d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

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 313
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K892730.
IFA SENSIBAC VANCOMYCIN
K892725 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989
IFA SENSIBAC INIPENEM
K892727 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989
IFA SENSIBAC TOBRAMYCIN
K892729 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · Organon Teknika Corp. · Nov 1987
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987