Cleared Traditional

K891604 - THE CEN-SLIDE(TM) CENTRIFUGE TUBE

K891604 is an FDA 510(k) clearance for THE CEN-SLIDE(TM) CENTRIFUGE TUBE, manufactured by Davstar California, Inc.. The device is a Class 1 Pathology device with product code KEW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K891604 · Davstar California, Inc. · Pathology device
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Jun 1989
Decision
88d
Days
Class 1
Risk

K891604 is an FDA 510(k) clearance for the THE CEN-SLIDE(TM) CENTRIFUGE TUBE. Classified as Slides, Microscope (product code KEW), Class I - General Controls.

Submitted by Davstar California, Inc. (Lawndale, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3010 - the FDA pathology 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.

FDA 510(k) Submission Details - K891604

510(k) Number K891604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date June 16, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 78d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

KEW Device Classification - Class 1, General Controls

Product Code KEW Slides, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
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 - KEW Slides, Microscope

Devices cleared under the same product code (KEW) and FDA review panel - the closest regulatory comparables to K891604.
SECTIONING AID KIT
K831065 · Technicon Instruments Corp. · Jun 1983
FROSTED GLASS SLIDES
K820100 · Stan-Pak Ent. · Mar 1982
QUANTIMETRIC 2 TEST KIT
K813242 · Kallestad Laboratories, Inc. · Dec 1981
ABCO ULTRA SLIDE MICROSCOPE SLIDE
K800232 · Abco Dealers, Inc. · Feb 1980
SLIDE, LAB-TEK COVERED MICRO
K760278 · Miles Laboratories, Inc. · Aug 1976