Cleared Traditional

K921844 - KODAK EKTACHEM DT SLIDES (NBIL)

K921844 is an FDA 510(k) clearance for KODAK EKTACHEM DT SLIDES (NBIL), manufactured by Eastman Kodak Company. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K921844 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
95d
Days
Class 2
Risk

K921844 is an FDA 510(k) clearance for the KODAK EKTACHEM DT SLIDES (NBIL). Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 - K921844

510(k) Number K921844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date July 21, 1992
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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.

Regulatory Peers - CIG Diazo Colorimetry, Bilirubin

All 217
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K921844.
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · Em Diagnostic Systems, Inc. · Sep 1992
OLYMPUS DIRECT BILIRUBIN REAGENT
K923608 · Olympus Corp. · Aug 1992
IL TEST BILIRUBIN TOTAL/DIRECT
K920653 · Instrumentation Laboratory CO · Jul 1992
DIAZO COLORIMETRY, BILIRUBIN
K914873 · Pointe Scientific, Inc., · Dec 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · Em Diagnostic Systems, Inc. · Oct 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · Em Diagnostic Systems, Inc. · Oct 1991