Cleared Traditional

K893838 - MODIFIED MODEL 570 CLINICAL CHEMISTRY A...

K893838 is an FDA 510(k) clearance for MODIFIED MODEL 570 CLINICAL CHEMISTRY A..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K893838 · Ciba Corning Diagnostics Corp. · Chemistry device
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Aug 1989
Decision
99d
Days
Class 1
Risk

K893838 is an FDA 510(k) clearance for the MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 99 days - within the typical 510(k) review window.

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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K893838

510(k) Number K893838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1989
Decision Date August 31, 1989
Days to Decision 99 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
11d slower than avg
Panel avg: 88d · This submission: 99d
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 50
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K893838.
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710 PLUS
K864557 · Ciba Corning Diagnostics Corp. · Feb 1987