Cleared Traditional

SOMAS CHLORIDE ASSAY KIT (K833787) - FDA 510(k) Clearance

K833787 · Somas Medical Industries, Inc. · Chemistry device
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Jan 1984
Decision
72d
Days
-
Risk

K833787 is an FDA 510(k) clearance for the SOMAS CHLORIDE ASSAY KIT.

Submitted by Somas Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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 Somas Medical Industries, Inc. devices

Submission Details

510(k) Number K833787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1983
Decision Date January 11, 1984
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -