Cleared Traditional

SYVA SAMPLE SEAL (K844949) - FDA 510(k) Clearance

Class I Toxicology device.

K844949 · Syva Co. · Toxicology device
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Feb 1985
Decision
57d
Days
Class 1
Risk

K844949 is an FDA 510(k) clearance for the SYVA SAMPLE SEAL. 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 February 15, 1985 after a review of 57 days - a notably fast clearance 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: 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 K844949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date February 15, 1985
Days to Decision 57 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
30d faster than avg
Panel avg: 87d · This submission: 57d
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 K844949.
EMIT ANCILLARY REAGENTS
K844947 · Syva Co. · Jun 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