FDA 510(k)

AMMONIA REAGENT

K-Number: K821719 · 1982-06-24

Decision Date1982-06-24

Product CodeJIF

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AMMONIA REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1982-06-24 under 510(k) number K821719. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMMONIA REAGENT?

AMMONIA REAGENT is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Gilford Diagnostics. The 510(k) number is K821719.

When did AMMONIA REAGENT receive FDA 510(k) clearance?

AMMONIA REAGENT received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821719.

Who is the listed applicant for AMMONIA REAGENT?

The FDA 510(k) record lists Gilford Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA REAGENT?

The FDA product code for AMMONIA REAGENT is JIF.

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Other records listing Gilford Diagnostics as applicant

K832094BILIRUBIN CALIBRATORS & CONTROL K831844DIRECT BILIRUBIN REAGENT K831843GILCHEM TOTAL BILIRUBIN REAGENT K823709TRIGLYCERIDE REAGENT (UV)K822739AHBD K822334BILIRUBIN CALIBRATORS

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Related Devices (Code: JIF)

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare Diagnostics K123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics K062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. Srl K033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.