Cleared Traditional

K811618 - EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL

K811618 is the FDA 510(k) clearance for EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL by Syva Co.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811618 · Syva Co. · Toxicology device
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Jun 1981
Decision
17d
Days
Class 1
Risk

K811618 is an FDA 510(k) clearance for the EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1981 after a review of 17 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 K811618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1981
Decision Date June 25, 1981
Days to Decision 17 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
70d faster than avg
Panel avg: 87d · This submission: 17d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K811618.
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
THERACHEM ANTI CONVULSANTA THEOPHYLLINE
K810504 · Fisher Scientific Co., LLC · Mar 1981
EMIT-ST SERUM CONTROLS
K810468 · Syva Co. · Mar 1981
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
K810078 · Hyland Therapeutic Div., Travenol Laboratories · Feb 1981