Cleared Traditional

EMIT ANCILLARY REAGENTS (K844947) - FDA 510(k) Clearance

Class I Toxicology device.

K844947 · Syva Co. · Toxicology device
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Jun 1985
Decision
190d
Days
Class 1
Risk

K844947 is an FDA 510(k) clearance for the EMIT ANCILLARY REAGENTS. Classified as Apparatus, High Pressure Liquid Chromatography (product code KIE), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 190 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Syva Co. devices

Submission Details

510(k) Number K844947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date June 28, 1985
Days to Decision 190 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
103d slower than avg
Panel avg: 87d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIE Apparatus, High Pressure Liquid Chromatography
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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 - KIE Apparatus, High Pressure Liquid Chromatography

All 24
Devices cleared under the same product code (KIE) and FDA review panel - the closest regulatory comparables to K844947.
SYVA SAMPLE SEAL
K844949 · Syva Co. · Feb 1985
DIFFERENTIAL REFRACTIVE INDEX DETECTOR
K800556 · Hewlett-Packard Co. · Mar 1980
DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.
K800516 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1980
DETECTOR, MODEL 79875A, VARIABLE
K781771 · Hewlett-Packard Co. · Dec 1978
AUTO. SAMPLING SYSTEM
K772364 · Hewlett-Packard Co. · Jan 1978
L080 SERIES LIQUID CHROMATOGRAPH
K761351 · Hewlett-Packard Co. · Feb 1977