FDA 510(k)

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

K-Number: K123322 · 2013-05-21

ApplicantAlfa Wassermann Diagnostics Technologies, LLC

Decision Date2013-05-21

Product CodeCDN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostics Technologies, LLC. It received FDA 510(k) clearance on 2013-05-21 under 510(k) number K123322. The device is classified under product code CDN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT is a medical device that received FDA 510(k) clearance on 2013-05-21. The listed applicant is Alfa Wassermann Diagnostics Technologies, LLC. The 510(k) number is K123322.

When did ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT receive FDA 510(k) clearance?

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT received FDA 510(k) clearance on 2013-05-21, under 510(k) number K123322.

Who is the listed applicant for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

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

What is the FDA product code for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT?

The FDA product code for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT is CDN.

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Other records listing Alfa Wassermann Diagnostics Technologies, LLC as applicant

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Related Devices (Code: CDN)

K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.K132462S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CREHitachi Chemical Diagnostics, Inc.K113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K103615ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDAlfa Wassermann Diagnostic Technologies, Inc.K001885VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1Ortho-Clinical Diagnostics, Inc.K972012CHOLESTECH BUN/CREATININE TEST SYSTEMCholestech Corp.

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.