Cleared Traditional

K894527 - FPR PHENYTOIN KIT

K894527 is an FDA 510(k) clearance for FPR PHENYTOIN KIT, manufactured by Colony Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DLP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K894527 · Colony Laboratories, Inc. · Toxicology device
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Sep 1989
Decision
67d
Days
Class 2
Risk

K894527 is an FDA 510(k) clearance for the FPR PHENYTOIN KIT. Classified as Radioimmunoassay, Diphenylhydantoin (product code DLP), Class II - Special Controls.

Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - the FDA toxicology device framework. 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 Colony Laboratories, Inc. devices

FDA 510(k) Submission Details - K894527

510(k) Number K894527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 25, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLP Device Classification - Class 2, Special Controls

Product Code DLP Radioimmunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.