Cleared Traditional

K935662 - SYNERMED IR 500 CHEMISTRY ANALYZER

K935662 is an FDA 510(k) clearance for SYNERMED IR 500 CHEMISTRY ANALYZER, manufactured by Synermed, Inc.. The device is a Class 1 Chemistry device with product code JIQ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K935662 · Synermed, Inc. · Chemistry device
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Apr 1994
Decision
151d
Days
Class 1
Risk

K935662 is an FDA 510(k) clearance for the SYNERMED IR 500 CHEMISTRY ANALYZER. Classified as Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.) (product code JIQ), Class I - General Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on April 26, 1994 after a review of 151 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Synermed, Inc. devices

FDA 510(k) Submission Details - K935662

510(k) Number K935662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date April 26, 1994
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

JIQ Device Classification - Class 1, General Controls

Product Code JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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 - JIQ Turbidimetric Method, Protein Or Albumin (urinary, Non-quant.)

All 11
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