Cleared Traditional

K903357 - SYVA ETS PLUS SYSTEM

K903357 is the FDA 510(k) clearance for SYVA ETS PLUS SYSTEM by Syva Co.. It is a Class 1 Chemistry device (product code JJF) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K903357 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
63d
Days
Class 1
Risk

K903357 is an FDA 510(k) clearance for the SYVA(R) ETS(R) PLUS SYSTEM. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 Syva Co. devices

Submission Details

510(k) Number K903357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1990
Decision Date September 27, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
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.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
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 - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 31
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K903357.
WINMAX SOFTWARE SYSTEMS
K965103 · Diagnostic Products Corp. · May 1997
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
K925093 · Beckman Instruments, Inc. · Nov 1993
SYVA EDMS
K912055 · Syva Co. · Jun 1991
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768 · Olympus Corp. · Aug 1989
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120 · Miles Laboratories, Inc. · Oct 1987
SYVA ETS SYSTEM
K863245 · Syva Co. · Mar 1987