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FDA 510(k)

AMMONIA ASSAY FOR THE ADVIA 1650

K-Number: K023841 · 2002-12-24

ApplicantBayer Diagnostics Corp.
Decision Date2002-12-24
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA ASSAY FOR THE ADVIA 1650 is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2002-12-24 under 510(k) number K023841. 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 ASSAY FOR THE ADVIA 1650?

AMMONIA ASSAY FOR THE ADVIA 1650 is a medical device that received FDA 510(k) clearance on 2002-12-24. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K023841.

When did AMMONIA ASSAY FOR THE ADVIA 1650 receive FDA 510(k) clearance?

AMMONIA ASSAY FOR THE ADVIA 1650 received FDA 510(k) clearance on 2002-12-24, under 510(k) number K023841.

Who is the listed applicant for AMMONIA ASSAY FOR THE ADVIA 1650?

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

What is the FDA product code for AMMONIA ASSAY FOR THE ADVIA 1650?

The FDA product code for AMMONIA ASSAY FOR THE ADVIA 1650 is JIF.

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Other records listing Bayer Diagnostics Corp. as applicant

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.

K033379BAYER SPECIAL CHEMISTRY CONTROLSK033380BAYER SPECIAL CHEMISTRY CALIBRATORSK033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMK031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLS

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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. SrlK033921AMMONIA-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.

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