Cleared Traditional

K801205 - EMIT DISOPYRAMIDE CONTROL

K801205 is the FDA 510(k) clearance for EMIT DISOPYRAMIDE CONTROL by Syva Co.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K801205 · Syva Co. · Toxicology device
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Jun 1980
Decision
21d
Days
Class 1
Risk

K801205 is an FDA 510(k) clearance for the EMIT DISOPYRAMIDE CONTROL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Syva Co. devices

Submission Details

510(k) Number K801205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1980
Decision Date June 09, 1980
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific 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 - LAS Drug Specific Control Materials

All 55
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K801205.
EMIT-CAD QUINDINE CONTROL
K811462 · Syva Co. · Jun 1981
AMES TDA AMIKACIN CONTROL SERUM
K803107 · Miles Laboratories, Inc. · Dec 1980
EMIT VALPROIC ACID CONTROL
K801206 · Syva Co. · Jun 1980
EMIT GENTAMICIN CONTROL
K790830 · Syva Co. · May 1979
EMIT-QUINIDINE CONTROL
K790402 · Syva Co. · Mar 1979
EMIT PROCAINAMIDE CONTROL SET
K782084 · Syva Co. · Jan 1979