FDA 510(k)

ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT

K-Number: K112538 · 2012-03-29

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.

Decision Date2012-03-29

Product CodeCHH

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT 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 2012-03-29 under 510(k) number K112538. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K112538.

When did ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT receive FDA 510(k) clearance?

ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT received FDA 510(k) clearance on 2012-03-29, under 510(k) number K112538.

Who is the listed applicant for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

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 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT?

The FDA product code for ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT is CHH.

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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

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Related Devices (Code: CHH)

K251091LipidsTruvian Health K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A K203597Cholesterol2Abbott Ireland Diagnostics Division K190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings K180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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.