Cleared Traditional

K831979 - EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO

K831979 is an FDA 510(k) clearance for EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO, 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 29-day FDA review.

K831979 · Syva Co. · Toxicology device
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Jul 1983
Decision
29d
Days
Class 1
Risk

K831979 is an FDA 510(k) clearance for the EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO. 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 July 19, 1983 after a review of 29 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 - K831979

510(k) Number K831979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date July 19, 1983
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
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 K831979.
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
MAPROTILINE
K831735 · Utak Laboratories, Inc. · Jul 1983
CAFFINE TOXICOLOGY CONTROL
K831738 · Utak Laboratories, Inc. · Jul 1983
PENTOBARBITAL TOXICOLOGY CONTROL
K831739 · Utak Laboratories, Inc. · Jul 1983
EMIT QST TOBRAMYCIN CONTROL
K831417 · Syva Co. · Jun 1983
ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL
K830049 · Syva Co. · Jan 1983