Synermed Chloride Reagent Kit

FDA 510(k) K903103 · Synermed, Inc.

Substantially Equivalent

510(k) numberK903103

Submission

Device name
Synermed Chloride Reagent Kit
Applicant
Synermed, Inc.
Quebec, Canada, CA
Received
July 13, 1990
Decision date
August 9, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CHG – Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1170
Specialty
Clinical Chemistry

Other 510(k)s with product code CHG

510(k)DeviceApplicantDecision
K941807Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional Intersect Systems, Inc.09/14/1994SE
K934588Chloride (MF) AssayCHG · Traditional Diagnostic Chemicals , Ltd.02/18/1994SE

More from Diagnostic Chemicals , Ltd.

510(k)DeviceDecision
K973109Synermed Near-Infrared Direct Bilirubin Reagent KitCIG · Traditional 09/25/1997SE
K972716Synermed Total Bilirubin Reagent KitCIG · Traditional 08/07/1997SE
K971491Synermed Ir 200 Chemistry AnalyzerJJF · Traditional 06/26/1997SE
K962479Synermed Ise ReagentsCGZ · Traditional 03/03/1997SE
K963939Synermed Direct Bilirubin Reagent KitCIG · Traditional 12/18/1996SE
K960793Synermed Enzymatic CO2 Reagent KitKHS · Traditional 03/11/1996SE
K953395Synermed Calcium Reagent KitCJY · Traditional 08/31/1995SE
K952179Synermed Ise ReagentsJGS · Traditional 06/20/1995SE
K943924Creatinine-Po Reagent KitCGX · Traditional 09/20/1994SE
K941091Synermed Amylase Reagent KitJFJ · Traditional 05/03/1994SE

Questions and answers

When was Synermed Chloride Reagent Kit cleared by the FDA?

Synermed Chloride Reagent Kit (K903103) received a 510(k) decision of Substantially Equivalent on August 9, 1990, 27 days after the submission was received.

What is the product code of K903103?

The FDA product code is CHG – Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.