Cleared Traditional

K782084 - EMIT PROCAINAMIDE CONTROL SET

K782084 is an FDA 510(k) clearance for EMIT PROCAINAMIDE CONTROL SET, manufactured by Syva Co.. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K782084 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1979
Decision
27d
Days
Class 1
Risk

K782084 is an FDA 510(k) clearance for the EMIT PROCAINAMIDE CONTROL SET. 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 January 10, 1979 after a review of 27 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

FDA 510(k) Submission Details - K782084

510(k) Number K782084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1978
Decision Date January 10, 1979
Days to Decision 27 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
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

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 69
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K782084.
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
K800357 · Ortho Diagnostics, Inc. · Apr 1980
EMIT GENTAMICIN CONTROL
K790830 · Syva Co. · May 1979
EMIT-QUINIDINE CONTROL
K790402 · Syva Co. · Mar 1979
CONTROL SET, EMIT METHOTREXATE
K781827 · Syva Co. · Jan 1979
THEOPHYLLINE CONTROL SERUM
K780961 · Vitek Systems, Inc. · Dec 1978