Cleared Traditional

K833746 - TECH. RA-1000 SYS SERUM CHLORIDE (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833746 · Technicon Instruments Corp. · Chemistry device
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Jan 1984
Decision
79d
Days
Class 2
Risk

K833746 is an FDA 510(k) clearance for the TECH. RA-1000 SYS SERUM CHLORIDE. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K833746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date January 13, 1984
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.