Cleared Traditional

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

Feb 1985
Decision
57d
Days
Class 1
Risk

K844949 is an FDA 510(k) clearance for the SYVA SAMPLE SEAL. This device is classified as a Apparatus, High Pressure Liquid Chromatography (Class I - General Controls, product code KIE).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on February 15, 1985, 57 days after receiving the submission on December 20, 1984.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2260.

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

Device Classification

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