Cleared Traditional

K883890 - DU PONT DIMENSION PSEUDOCHOLINESTERASE ...

K883890 is the FDA 510(k) clearance for DU PONT DIMENSION PSEUDOCHOLINESTERASE ... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 1 Chemistry device (product code DIH) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K883890 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Nov 1988
Decision
76d
Days
Class 1
Risk

K883890 is an FDA 510(k) clearance for the DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3240 - the FDA in vitro diagnostics and chemistry 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 K883890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1988
Decision Date November 29, 1988
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIH Colorimetry, Cholinesterase

All 17
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K883890.
ATYPICAL CHOLINESTERASE
K873496 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE
K880049 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE
K880199 · Sclavo, Inc. · Jan 1989
CHOLINESTERASE (BTC) REAGENT
K863203 · Sigma Diagnostics, Inc. · Sep 1986
CHOLINESTERASE (PTC) REAGENT
K863202 · Sigma Diagnostics, Inc. · Sep 1986
CHOLINESTERASE
K863111 · J. D. Assoc. · Sep 1986