Cleared Traditional

K844947 - EMIT ANCILLARY REAGENTS

K844947 is an FDA 510(k) clearance for EMIT ANCILLARY REAGENTS, manufactured by Syva Co.. The device is a Class 1 Toxicology device with product code KIE cleared through the Traditional 510(k) pathway after a 190-day FDA review.

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

FDA 510(k) Submission Details - K844947

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.

KIE Device Classification - Class 1, General Controls

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 14
Devices cleared under the same product code (KIE) and FDA review panel - the closest regulatory comparables to K844947.
WATERS(TM) 996 PDA
K924347 · Millipore Corp. · Dec 1992
CHROMATOGRAPHY CLINICAL USE 75JQR
K914841 · Millipore Corp. · Dec 1991
THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
K862506 · Millipore Corp. · Jul 1986
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