FDA 510(k)

S40 CLINICAL ANALYZER, S TEST IP, S TEST UA

K-Number: K072141 · 2008-06-24

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.

Decision Date2008-06-24

Product CodeCEO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

S40 CLINICAL ANALYZER, S TEST IP, S TEST UA is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K072141. 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 S40 CLINICAL ANALYZER, S TEST IP, S TEST UA?

S40 CLINICAL ANALYZER, S TEST IP, S TEST UA is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K072141.

When did S40 CLINICAL ANALYZER, S TEST IP, S TEST UA receive FDA 510(k) clearance?

S40 CLINICAL ANALYZER, S TEST IP, S TEST UA received FDA 510(k) clearance on 2008-06-24, under 510(k) number K072141.

Who is the listed applicant for S40 CLINICAL ANALYZER, S TEST IP, S TEST UA?

The FDA 510(k) record lists Alfa Wassermann Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S40 CLINICAL ANALYZER, S TEST IP, S TEST UA?

The FDA product code for S40 CLINICAL ANALYZER, S TEST IP, S TEST UA 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alfa Wassermann Diagnostic Technologies, Inc. as applicant

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT K113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT K113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

View all 21 devices →

Related Devices (Code: CEO)

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan Diagnostics K022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic K003912PHOSPHORUS REAGENTJas Diagnostics, Inc.

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.