Cleared Traditional

SYNERMED CHLORIDE REAGENT KIT

K903103 · Synermed, Inc. · Chemistry
Aug 1990
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K903103 is an FDA 510(k) clearance for the SYNERMED CHLORIDE REAGENT KIT, a Acid, Phosphoric-tungstic (spectrophotometric), Chloride (Class II — Special Controls, product code CHG), submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on August 9, 1990, 27 days after receiving the submission on July 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K903103 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1990
Decision Date August 09, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code CHG — Acid, Phosphoric-tungstic (spectrophotometric), Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170