Cleared Traditional

K930208 - CHOLINESTERASE METHOD FOR TECHNICON CHE...

K930208 is the FDA 510(k) clearance for CHOLINESTERASE METHOD FOR TECHNICON CHE... by Heraeus Kulzer, Inc.. It is a Class 1 Toxicology device (product code DLI) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K930208 · Heraeus Kulzer, Inc. · Toxicology device
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Apr 1993
Decision
95d
Days
Class 1
Risk

K930208 is an FDA 510(k) clearance for the CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO. Classified as Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase (product code DLI), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3240 - 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K930208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1993
Decision Date April 20, 1993
Days to Decision 95 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
8d slower than avg
Panel avg: 87d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DLI Acetylcholine Chloride, Specific Reagent For Pseudo 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 - DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Devices cleared under the same product code (DLI) and FDA review panel - the closest regulatory comparables to K930208.
DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD
K950180 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
SERUM CHOLINESTERASE REAGENT SET
K860350 · Sterling Diagnostics, Inc. · Apr 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641 · Em Diagnostic Systems, Inc. · Apr 1986
CHOLINESTERASE REAGENT SYSTEM
K771024 · American Monitor Corp. · Jul 1977