FDA 510(k)

SIGMA AMMONIA REAGENT

K-Number: K760332 · 1976-08-23

Decision Date1976-08-23

Product CodeJIF

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SIGMA AMMONIA REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1976-08-23 under 510(k) number K760332. 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 SIGMA AMMONIA REAGENT?

SIGMA AMMONIA REAGENT is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is Sigma Chemical Co.. The 510(k) number is K760332.

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

SIGMA AMMONIA REAGENT received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760332.

Who is the listed applicant for SIGMA AMMONIA REAGENT?

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

What is the FDA product code for SIGMA AMMONIA REAGENT?

The FDA product code for SIGMA AMMONIA REAGENT is JIF.

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Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

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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

View on FDA Database →

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