Cleared Traditional

K831838 - LABORATORY DATA MGMT SYSTEM SDMS (FDA 510(k) Clearance)

Class I Chemistry device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
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.