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FDA 510(k)

HICHEM PHOSPHORUS REAGENT KIT

K-Number: K981769 · 1998-06-29

ApplicantElan Pharma, Inc.
Decision Date1998-06-29
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM PHOSPHORUS REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Pharma, Inc.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981769. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM PHOSPHORUS REAGENT KIT?

HICHEM PHOSPHORUS REAGENT KIT is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Elan Pharma, Inc.. The 510(k) number is K981769.

When did HICHEM PHOSPHORUS REAGENT KIT receive FDA 510(k) clearance?

HICHEM PHOSPHORUS REAGENT KIT received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981769.

Who is the listed applicant for HICHEM PHOSPHORUS REAGENT KIT?

The FDA 510(k) record lists Elan Pharma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HICHEM PHOSPHORUS REAGENT KIT?

The FDA product code for HICHEM PHOSPHORUS REAGENT KIT is CEO.

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 Elan Pharma, Inc. 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.

K982469HICHEM CHOLESTEROL REAGENT KITK962247HICHEM CK/NAC REAGENT KITK960115HICHEM BUN/UREA REAGENT KIT

Related Devices (Code: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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.

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