Cleared Traditional

K971210 - SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML TH...

K971210 is an FDA 510(k) clearance for SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML TH..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K971210 · Beckman Instruments, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
15d
Days
Class 1
Risk

K971210 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on April 17, 1997 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Instruments, Inc. devices

FDA 510(k) Submission Details - K971210

510(k) Number K971210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1997
Decision Date April 17, 1997
Days to Decision 15 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
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - LAS Drug Specific Control Materials

All 55
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