Cleared Traditional

K983209 - SYNCHRON SYSTEMS DAT LOW AND HIGH URINE...

K983209 is the FDA 510(k) clearance for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE... by Beckman Coulter, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K983209 · Beckman Coulter, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
51d
Days
Class 2
Risk

K983209 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 4, 1998 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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: 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

Submission Details

510(k) Number K983209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date November 04, 1998
Days to Decision 51 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
36d faster than avg
Panel avg: 87d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 - DKB Calibrators, Drug Mixture

All 77
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K983209.
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255 · Dade Behring, Inc. · Feb 1999
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
K983747 · Beckman Coulter, Inc. · Dec 1998
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · Diagnostic Reagents, Inc. · Nov 1998
DRUG CALIBRATOR II
K982871 · Dade Behring, Inc. · Oct 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403 · Beckman Instruments, Inc. · May 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
K980853 · Boehringer Mannheim Corp. · Apr 1998