Cleared Traditional

K831838 - LABORATORY DATA MGMT SYSTEM SDMS

K831838 is an FDA 510(k) clearance for LABORATORY DATA MGMT SYSTEM SDMS, manufactured by Vickers America Medical Corp.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K831838 · Vickers America Medical Corp. · Chemistry device
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Jan 1984
Decision
231d
Days
Class 1
Risk

K831838 is an FDA 510(k) clearance for the LABORATORY DATA MGMT SYSTEM SDMS. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Vickers America Medical Corp. (Walker, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 231 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Vickers America Medical Corp. devices

FDA 510(k) Submission Details - K831838

510(k) Number K831838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1983
Decision Date January 24, 1984
Days to Decision 231 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
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

JQP Device Classification - Class 1, General Controls

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 55
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K831838.
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
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K832746 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1983
CORNING 102 PRINTER
K830296 · Corning Medical & Scientific · Mar 1983