Cleared Traditional

K771245 - MODEL 2/2 ANALYZER

K771245 is the FDA 510(k) clearance for MODEL 2/2 ANALYZER by Eastman Kodak Company. It is a Class 1 Hematology device (product code JJE) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K771245 · Eastman Kodak Company · Hematology device
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Oct 1977
Decision
88d
Days
Class 1
Risk

K771245 is an FDA 510(k) clearance for the MODEL 2/2 ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Eastman Kodak Company (Mchenry, US). The FDA issued a Cleared decision on October 7, 1977 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2160 - the FDA hematology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K771245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1977
Decision Date October 07, 1977
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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.

Regulatory Peers - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 142
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K771245.
ANALYZER ABA-200
K782014 · Abbott Laboratories · Jan 1979
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528 · Coulter Electronics, Inc. · Sep 1978
ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · Syva Co. · Mar 1978
BICHROMATIC ANALYZER ABA-200
K771345 · Abbott Laboratories · Aug 1977
CHEMISTRY, COULTER
K770679 · Coulter Electronics, Inc. · May 1977