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FDA 510(k)

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

K-Number: K033921 · 2004-03-10

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2004-03-10
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2004-03-10 under 510(k) number K033921. 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-L3K ASSAY, CATALOGUE NUMBER 233-10?

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 is a medical device that received FDA 510(k) clearance on 2004-03-10. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K033921.

When did AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 receive FDA 510(k) clearance?

AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 received FDA 510(k) clearance on 2004-03-10, under 510(k) number K033921.

Who is the listed applicant for AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10?

The FDA product code for AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 is JIF.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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Related Devices (Code: JIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK030873RANDOX AMMONIARandox Laboratories, 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.

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