Cleared Traditional

K993023 - SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS

K993023 is an FDA 510(k) clearance for SYNCHRON SYSTEMS OP 300 LOW AND HIGH UR..., manufactured by Beckman Coulter, Inc.. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K993023 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
78d
Days
Class 1
Risk

K993023 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K993023

510(k) Number K993023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date November 26, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 105d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 593
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