Ammonia Reagent

FDA 510(k) K821719 · Gilford Diagnostics

Substantially Equivalent

510(k) numberK821719

Submission

Device name
Ammonia Reagent
Applicant
Gilford Diagnostics
Mchenry, IL, US
Received
June 10, 1982
Decision date
June 24, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIF – Enzymatic Method, Ammonia
Device class
Class I (low risk)
Regulation
21 CFR 862.1065
Specialty
Clinical Chemistry

Other 510(k)s with product code JIF

510(k)DeviceApplicantDecision
K183517Ammonia IIJIF · Traditional Roche Diagnostics Operations (Rdo)02/08/2019SE
K123677Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal)JIF · Traditional Siemens Healthcare Diagnostics03/07/2013SE
K123320Dimension Ammonia Flex Reagent CartridgeJIF · Traditional Siemens Healthcare Diagnostics02/15/2013SE
K062316Dimension Vista Ammonia (Amon) Flex Reagent CartridgeJIF · Special Dade Behring, Inc.09/06/2006SE
K051114Sentinel Ammonia Ultra Diagnostic AssayJIF · Traditional Sentinel Ch. Srl11/25/2005SE
K033921AMMONIA-L3K Assay, Catalogue Number 233-10JIF · Traditional Diagnostic Chemicals , Ltd.03/10/2004SE
K030873Randox AmmoniaJIF · Traditional Randox Laboratories, Ltd.05/12/2003SE
K023841Ammonia Assay for the Advia 1650JIF · Traditional Bayer Diagnostics Corp.12/24/2002SE
K021151Ammonia Assay for the Advia Integrated Modular SystemJIF · Traditional Bayer Diagnostics Corp.07/13/2002SE
K003196Synchron Systems Ammonia ReagentJIF · Traditional Beckman Coulter, Inc.12/22/2000SE

More from Beckman Coulter, Inc.

510(k)DeviceDecision
K832094Bilirubin Calibrators & ControlJIT · Traditional 08/11/1983SE
K831844Direct Bilirubin ReagentCIG · Traditional 07/18/1983SE
K831843Gilchem Total Bilirubin ReagentCIG · Traditional 07/18/1983SE
K823709Triglyceride Reagent (UV)CDT · Traditional 01/07/1983SE
K822739AhbdJMK · Traditional 10/18/1982SE
K822334Bilirubin CalibratorsJIT · Traditional 09/02/1982SE
K822289CO2/CI StandardsJIX · Traditional 08/24/1982SE
K822149Gilchem Y-Gt ReagentJPZ · Traditional 08/12/1982SE
K820976Gil Chem Magnesium ReagentJGJ · Traditional 04/26/1982SE
K820975Gilchem Acid Phosphatase ReagentCKB · Traditional 04/26/1982SE

Questions and answers

When was Ammonia Reagent cleared by the FDA?

Ammonia Reagent (K821719) received a 510(k) decision of Substantially Equivalent on June 24, 1982, 14 days after the submission was received.

What is the product code of K821719?

The FDA product code is JIF – Enzymatic Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.