Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K-Number: K021151 · 2002-07-13

ApplicantBayer Diagnostics Corp.
Decision Date2002-07-13
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM 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 2002-07-13 under 510(k) number K021151. 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 INTEGRATED MODULAR SYSTEM?

AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-13. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K021151.

When did AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM receive FDA 510(k) clearance?

AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM received FDA 510(k) clearance on 2002-07-13, under 510(k) number K021151.

Who is the listed applicant for AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

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 INTEGRATED MODULAR SYSTEM?

The FDA product code for AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is JIF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 32 devices →

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.

↑