Cleared Traditional

K820286 - SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL

K820286 is the FDA 510(k) clearance for SYVA ADVANCE SY. EMIT-AMD GENT. 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.

K820286 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
21d
Days
Class 1
Risk

K820286 is an FDA 510(k) clearance for the SYVA ADVANCE SY. EMIT-AMD GENT. 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 February 23, 1982 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 K820286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1982
Decision Date February 23, 1982
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 K820286.
EMIT TOX ACETAMINOPHEN CONTROL
K821380 · Syva Co. · Jun 1982
EMIT-AMD AMIKACIN CONTROL
K820439 · Syva Co. · Mar 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
K820392 · Ortho Diagnostic Systems, Inc. · Mar 1982
EMIT AND NETILMICIN CONTROL
K820323 · Syva Co. · Feb 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL
K820129 · Syva Co. · Jan 1982
EMIT-AAD THEOPHYLLINE CONTROL
K813241 · Syva Co. · Dec 1981