Cleared Traditional

K843161 - EMIT 700 CONTROL SET A

K843161 is the FDA 510(k) clearance for EMIT 700 CONTROL SET A by Syva Co.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K843161 · Syva Co. · Toxicology device
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Aug 1984
Decision
19d
Days
Class 1
Risk

K843161 is an FDA 510(k) clearance for the EMIT 700 CONTROL SET A. 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 August 29, 1984 after a review of 19 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 K843161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date August 29, 1984
Days to Decision 19 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
68d faster than avg
Panel avg: 87d · This submission: 19d
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 K843161.
COBAS FP TDM CONTROLS
K843913 · Roche Diagnostic Systems, Inc. · Oct 1984
HUMAN SERUM CARDIOACTIVE DRUG CONTROL
K843679 · Quantimetrix Corp. · Oct 1984
EMIT 700 CONTROL SET B
K843508 · Syva Co. · Sep 1984
COMA TOXICOLOGY CONTROL
K841439 · American Dade · May 1984
LYPHOCHEK THERAPEUTIC DRUG CONTROL
K833794 · Bio-Rad · Jan 1984
TRI-LEVEL TDM CONTROL & I II III
K831500 · Ortho Diagnostic Systems, Inc. · Jun 1983