Cleared Traditional

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST (K780709) - FDA 510(k) Clearance

K780709 · Clinical Assays, Inc. · Toxicology device
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May 1978
Decision
16d
Days
-
Risk

K780709 is an FDA 510(k) clearance for the IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST.

Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 12, 1978 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology 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 Clinical Assays, Inc. devices

Submission Details

510(k) Number K780709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1978
Decision Date May 12, 1978
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -