Cleared Traditional

SALMONELLA IFA* (K885114) - FDA 510(k) Clearance

Class I Microbiology device.

K885114 · Investigacion Farmaceutica S.A. DE C.V. · Microbiology device
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Aug 1989
Decision
246d
Days
Class 1
Risk

K885114 is an FDA 510(k) clearance for the SALMONELLA IFA*. Classified as Tube, Sedimentation Rate (product code GHC), Class I - General Controls.

Submitted by Investigacion Farmaceutica S.A. DE C.V. (Mexico, MX). The FDA issued a Cleared decision on August 15, 1989 after a review of 246 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.6700 - 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

Submission Details

510(k) Number K885114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date August 15, 1989
Days to Decision 246 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 102d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GHC Tube, Sedimentation Rate
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6700
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.