Cleared Traditional

UNION CARBIDE CORP. COMPUTER INTERFACE (K790336) - FDA 510(k) Clearance

Class I Chemistry device.

K790336 · Union Carbide Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
42d
Days
Class 1
Risk

K790336 is an FDA 510(k) clearance for the UNION CARBIDE CORP. COMPUTER INTERFACE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 42 days - a notably fast clearance 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: 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 Union Carbide Corp. devices

Submission Details

510(k) Number K790336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1979
Decision Date April 04, 1979
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 30
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K790336.
3388 REPORTING INTEGRATOR
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K780881 · Syva Co. · Jun 1978