Cleared Traditional

K895505 - KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES) (FDA 510(k) Clearance)

Class I Microbiology device.

K895505 · Eastman Kodak Company · Microbiology device
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Jan 1990
Decision
113d
Days
Class 1
Risk

K895505 is an FDA 510(k) clearance for the KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES). Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on January 2, 1990 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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.

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Submission Details

510(k) Number K895505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date January 02, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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.