Cleared Traditional

K801565 - CYBREX PHENYTOIN (FDA 510(k) Clearance)

K801565 · Abbott Laboratories · Toxicology device
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Jul 1980
Decision
13d
Days
-
Risk

K801565 is an FDA 510(k) clearance for the CYBREX PHENYTOIN.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 13 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.

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Submission Details

510(k) Number K801565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date July 21, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 87d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -