Cleared Traditional

K833806 - CHEMKIT PHENYTOIN DIAG. KIT

K833806 is an FDA 510(k) clearance for CHEMKIT PHENYTOIN DIAG. KIT, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DIP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K833806 · Abbott Laboratories · Toxicology device
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Jan 1984
Decision
90d
Days
Class 2
Risk

K833806 is an FDA 510(k) clearance for the CHEMKIT PHENYTOIN DIAG. KIT. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K833806

510(k) Number K833806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1983
Decision Date January 30, 1984
Days to Decision 90 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
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIP Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K833806.
PHENYTOIN ACA ANALYTICAL TEST PACK
K843209 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
VENTREZYME PHENYTOIN KIT IMMUNOASSAY
K842161 · Ventrex Laboratories, Inc. · Jul 1984
EMIT QST PHENYTOIN ASSAY
K834406 · Syva Co. · Feb 1984
A-GENT PHERYTOIN
K832419 · Abbott Laboratories · Sep 1983
EMIT AED PHENYTOIN ASSAY
K832033 · Syva Co. · Aug 1983
VIRGO IPA FOR DETECTION OF PHENYTOIN
K811745 · Electro-Nucleonics Laboratories, Inc. · Jul 1981