Cleared Traditional

K870035 - KODAK EKTACHEM DT SLIDES (CA)

K870035 is an FDA 510(k) clearance for KODAK EKTACHEM DT SLIDES (CA), manufactured by Eastman Kodak Company. The device is a Class 2 Chemistry device with product code CID cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K870035 · Eastman Kodak Company · Chemistry device
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May 1987
Decision
127d
Days
Class 2
Risk

K870035 is an FDA 510(k) clearance for the KODAK EKTACHEM DT SLIDES (CA). Classified as Alizarin Sulfonate, Calcium (product code CID), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Eastman Kodak Company devices

FDA 510(k) Submission Details - K870035

510(k) Number K870035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1987
Decision Date May 12, 1987
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CID Device Classification - Class 2, Special Controls

Product Code CID Alizarin Sulfonate, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 Chemistry devices follow this clearance model.