Cleared Traditional

K852306 - REPLACEMENT REAGENTS FOR SMAC II SYSTEMS

K852306 is an FDA 510(k) clearance for REPLACEMENT REAGENTS FOR SMAC II SYSTEMS, manufactured by Methodist Hospital of Memphis. The device is a Class 1 Chemistry device with product code JJC cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K852306 · Methodist Hospital of Memphis · Chemistry device
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Aug 1985
Decision
65d
Days
Class 1
Risk

K852306 is an FDA 510(k) clearance for the REPLACEMENT REAGENTS FOR SMAC II SYSTEMS. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Methodist Hospital of Memphis (Memphis, US). The FDA issued a Cleared decision on August 2, 1985 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2150 - 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 Methodist Hospital of Memphis devices

FDA 510(k) Submission Details - K852306

510(k) Number K852306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date August 02, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

JJC Device Classification - Class 1, General Controls

Product Code JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2150
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 - JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

All 22
Devices cleared under the same product code (JJC) and FDA review panel - the closest regulatory comparables to K852306.
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