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FDA 510(k)

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT

K-Number: K131515 · 2013-08-14

ApplicantAlfa Wassermann
Decision Date2013-08-14
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann. It received FDA 510(k) clearance on 2013-08-14 under 510(k) number K131515. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT?

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT is a medical device that received FDA 510(k) clearance on 2013-08-14. The listed applicant is Alfa Wassermann. The 510(k) number is K131515.

When did ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT receive FDA 510(k) clearance?

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT received FDA 510(k) clearance on 2013-08-14, under 510(k) number K131515.

Who is the listed applicant for ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT?

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

What is the FDA product code for ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT?

The FDA product code for ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT is KLI.

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Other records listing Alfa Wassermann 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.

K113382ACE ALT REAGENTK113436ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENTK113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, Inc.K001603REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)Repromedix 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.

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