Cleared Traditional

REAGENTS (K761086) - FDA 510(k) Clearance

Class I Chemistry device.

K761086 · Simmler & Son, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1977
Decision
58d
Days
Class 1
Risk

K761086 is an FDA 510(k) clearance for the REAGENTS. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Simmler & Son, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1977 after a review of 58 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 Simmler & Son, Inc. devices

Submission Details

510(k) Number K761086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1976
Decision Date January 12, 1977
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 31
Devices cleared under the same product code (JJC) and FDA review panel - the closest regulatory comparables to K761086.
PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
K901141 · Baxter Healthcare Corp · Apr 1990
LANCER ANALYZER CUPS
K833157 · Sherwood Medical Co. · Dec 1983
BMC RIAFLO SYSTEM
K801481 · Boehringer Mannheim Corp. · Aug 1980
ANALYZER, GLUCOSE/UREA/CREATININE
K760211 · Instrumentation Laboratory CO · Aug 1976