Cleared Traditional

K944932 - PHENOBARBITAL FLEX REAGENT CARTRIDGE

K944932 is an FDA 510(k) clearance for PHENOBARBITAL FLEX REAGENT CARTRIDGE, manufactured by Dupont Medical Products. The device is a Class 2 Toxicology device with product code DLZ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K944932 · Dupont Medical Products · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
83d
Days
Class 2
Risk

K944932 is an FDA 510(k) clearance for the PHENOBARBITAL FLEX REAGENT CARTRIDGE. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K944932

510(k) Number K944932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1994
Decision Date December 28, 1994
Days to Decision 83 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 87d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLZ Device Classification - Class 2, Special Controls

Product Code DLZ Enzyme Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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.

Regulatory Peers - DLZ Enzyme Immunoassay, Phenobarbital

All 32
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K944932.
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