Cleared Traditional

K850659 - SYVA 700 SYSTEM ACCESSORIES-CLINICAL CH...

K850659 is the FDA 510(k) clearance for SYVA 700 SYSTEM ACCESSORIES-CLINICAL CH... by Syva Co.. It is a Class 1 Toxicology device (product code JQP) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K850659 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
40d
Days
Class 1
Risk

K850659 is an FDA 510(k) clearance for the SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 1, 1985 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2100 - the FDA toxicology device 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 K850659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1985
Decision Date April 01, 1985
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 46
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K850659.
GLUCOFACTS DATA PRINTER
K861779 · Miles Laboratories, Inc. · Aug 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · Miles Laboratories, Inc. · Jul 1986
DIRECT READOUT MODULE ACCESSORY
K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · Miles Laboratories, Inc. · Jan 1985
GELSCAN SOFTWARE 2190
K834490 · Lkb Instruments, Inc. · May 1984
HYBRITECH DATA STATION
K834300 · Hybritech, Inc. · Feb 1984