Cleared Traditional

K983747 - SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II

K983747 is an FDA 510(k) clearance for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Toxicology device with product code DKB cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K983747 · Beckman Coulter, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
68d
Days
Class 2
Risk

K983747 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II. 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 December 30, 1998 after a review of 68 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

FDA 510(k) Submission Details - K983747

510(k) Number K983747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1998
Decision Date December 30, 1998
Days to Decision 68 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
19d faster than avg
Panel avg: 87d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKB Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K983747.
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
K993954 · Beckman Coulter, Inc. · Jan 2000
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · Syva Co. · Dec 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255 · Dade Behring, Inc. · Feb 1999
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · Diagnostic Reagents, Inc. · Nov 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209 · Beckman Coulter, Inc. · Nov 1998
DRUG CALIBRATOR II
K982871 · Dade Behring, Inc. · Oct 1998