Cleared Traditional

ASSAY SYSTEM, GAMMAFLO, AUTOMATED (K781659) - FDA 510(k) Clearance

K781659 · E. R. Squibb & Sons, Inc. · Toxicology device
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Oct 1978
Decision
26d
Days
-
Risk

K781659 is an FDA 510(k) clearance for the ASSAY SYSTEM, GAMMAFLO, AUTOMATED.

Submitted by E. R. Squibb & Sons, Inc. (New York, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 26 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 E. R. Squibb & Sons, Inc. devices

Submission Details

510(k) Number K781659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1978
Decision Date October 24, 1978
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -