Cleared Traditional

K811886 - CESIUM DILUENT 7.5M
(FDA 510(k) Clearance)

Jul 1981
Decision
22d
Days
Class 2
Risk

K811886 is an FDA 510(k) clearance for the CESIUM DILUENT 7.5M. This device is classified as a Flame Photometry, Sodium (Class II - Special Controls, product code JGT).

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981, 22 days after receiving the submission on July 1, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.

Submission Details

510(k) Number K811886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 23, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JGT — Flame Photometry, Sodium
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.1665

Similar Devices — JGT Flame Photometry, Sodium

All 7
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
K896829 · Technicon Instruments Corp. · Feb 1990
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
K891574 · Em Diagnostic Systems, Inc. · Jun 1989
COMPONENTS FOR POTASSIUM, SODIUM CHLO
K841610 · Shaban Mfg. Co. · May 1984
SODIUM/POTASSIUM REAGENT SYS
K840216 · Sclavo, Inc. · Mar 1984
PARALLEL FLAME PHOTOMETER & SODIUM
K834248 · American Monitor Corp. · Jan 1984
KLINAR REAGENT PAK, #36010
K801892 · Hi Chem, Inc. · Oct 1980