Cleared Traditional

K904589 - KODAK SURECELL(TM) STREP A CONTROL FLUI...

K904589 is the FDA 510(k) clearance for KODAK SURECELL(TM) STREP A CONTROL FLUI... by Eastman Kodak Company. It is a Class 1 Microbiology device (product code GTY) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K904589 · Eastman Kodak Company · Microbiology device
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Jan 1991
Decision
101d
Days
Class 1
Risk

K904589 is an FDA 510(k) clearance for the KODAK SURECELL(TM) STREP A CONTROL FLUID SET. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K904589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date January 18, 1991
Days to Decision 101 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 102d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTY Antigens, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTY Antigens, All Groups, Streptococcus Spp.

All 29
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K904589.
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