Cleared Traditional

K811811 - TDM ANTI-CONVULSANT CONTROL LEVELS I-II

K811811 is the FDA 510(k) clearance for TDM ANTI-CONVULSANT CONTROL LEVELS I-II by Environmental Chemical Specialties. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811811 · Environmental Chemical Specialties · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
15d
Days
Class 1
Risk

K811811 is an FDA 510(k) clearance for the TDM ANTI-CONVULSANT CONTROL LEVELS I-II. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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 Environmental Chemical Specialties devices

Submission Details

510(k) Number K811811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1981
Decision Date July 10, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 149
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K811811.
CONTROL SET
K820191 · Syva Co. · Feb 1982
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · Stanbio Laboratory · Dec 1981
THERAPEUTIC DRUG CONTROL
K811756 · Icl Scientific · Jul 1981
EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL
K811618 · Syva Co. · Jun 1981
THERACHEM ANTI CONVULSANTA THEOPHYLLINE
K810504 · Fisher Scientific Co., LLC · Mar 1981
EMIT-ST SERUM CONTROLS
K810468 · Syva Co. · Mar 1981