Cleared Traditional

K934106 - KODAK EKTACHEM DTSC II SLIDES (LI)

K934106 is an FDA 510(k) clearance for KODAK EKTACHEM DTSC II SLIDES (LI), manufactured by Eastman Kodak Company. The device is a Class 2 Toxicology device with product code JIH cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K934106 · Eastman Kodak Company · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
245d
Days
Class 2
Risk

K934106 is an FDA 510(k) clearance for the KODAK EKTACHEM DTSC II SLIDES (LI). Classified as Flame Photometry, Lithium (product code JIH), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 25, 1994 after a review of 245 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3560 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eastman Kodak Company devices

FDA 510(k) Submission Details - K934106

510(k) Number K934106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date April 25, 1994
Days to Decision 245 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 87d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIH Device Classification - Class 2, Special Controls

Product Code JIH Flame Photometry, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
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 Toxicology devices follow this clearance model.

Regulatory Peers - JIH Flame Photometry, Lithium

All 10
Devices cleared under the same product code (JIH) and FDA review panel - the closest regulatory comparables to K934106.
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
K050338 · Akers Biosciences, Inc. · Mar 2005
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · Dade Behring, Inc. · Jun 2001
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI)
K924488 · Eastman Kodak Company · Jan 1993
MODEL 654 ANALYZER
K921403 · Ciba Corning Diagnostics Corp. · Jul 1992
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · Baxter Healthcare Corp · Dec 1989
TDX(R) LITES(TM) LITHIUM
K894328 · Abbott Laboratories · Nov 1989