Cleared Traditional

K880011 - REVISED LABELING FOR ADX PHENCYCLIDINE (FDA 510(k) Clearance)

K880011 · Abbott Laboratories · Toxicology device
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Feb 1988
Decision
38d
Days
-
Risk

K880011 is an FDA 510(k) clearance for the REVISED LABELING FOR ADX PHENCYCLIDINE. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 38 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 K880011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1988
Decision Date February 11, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 87d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCL Radioimmunoassay, Phencyclidine
Device Class -