Cleared Traditional

K972409 - AG CHEMISTRY ANALYZER SYSTEM

K972409 is an FDA 510(k) clearance for AG CHEMISTRY ANALYZER SYSTEM, manufactured by Landmark Scientific, Inc.. The device is a Class 1 Chemistry device with product code JJG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K972409 · Landmark Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
63d
Days
Class 1
Risk

K972409 is an FDA 510(k) clearance for the AG CHEMISTRY ANALYZER SYSTEM. Classified as Analyzer, Chemistry, Centrifugal, For Clinical Use (product code JJG), Class I - General Controls.

Submitted by Landmark Scientific, Inc. (Rockville, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2140 - the FDA in vitro diagnostics and chemistry 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 Landmark Scientific, Inc. devices

FDA 510(k) Submission Details - K972409

510(k) Number K972409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date August 28, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

JJG Device Classification - Class 1, General Controls

Product Code JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2140
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 - JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

All 22
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