Cleared Traditional

K843209 - PHENYTOIN ACA ANALYTICAL TEST PACK

K843209 is the FDA 510(k) clearance for PHENYTOIN ACA ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K843209 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Oct 1984
Decision
57d
Days
Class 2
Risk

K843209 is an FDA 510(k) clearance for the PHENYTOIN ACA ANALYTICAL TEST PACK. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on October 11, 1984 after a review of 57 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K843209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1984
Decision Date October 11, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIP Enzyme Immunoassay, 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.

Regulatory Peers - DIP Enzyme Immunoassay, Diphenylhydantoin

All 36
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K843209.
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EMIT PHENYTOIN ASSAY
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VENTREZYME PHENYTOIN KIT IMMUNOASSAY
K842161 · Ventrex Laboratories, Inc. · Jul 1984
EMIT QST PHENYTOIN ASSAY
K834406 · Syva Co. · Feb 1984
CHEMKIT PHENYTOIN DIAG. KIT
K833806 · Abbott Laboratories · Jan 1984