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FDA 510(k)

S-TEST CREATININE (CRE)

K-Number: K080073 · 2008-06-30

ApplicantAlfa Wassermann, Inc.
Decision Date2008-06-30
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S-TEST CREATININE (CRE) is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann, Inc.. It received FDA 510(k) clearance on 2008-06-30 under 510(k) number K080073. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-TEST CREATININE (CRE)?

S-TEST CREATININE (CRE) is a medical device that received FDA 510(k) clearance on 2008-06-30. The listed applicant is Alfa Wassermann, Inc.. The 510(k) number is K080073.

When did S-TEST CREATININE (CRE) receive FDA 510(k) clearance?

S-TEST CREATININE (CRE) received FDA 510(k) clearance on 2008-06-30, under 510(k) number K080073.

Who is the listed applicant for S-TEST CREATININE (CRE)?

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

What is the FDA product code for S-TEST CREATININE (CRE)?

The FDA product code for S-TEST CREATININE (CRE) is JFY.

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Other records listing Alfa Wassermann, Inc. as applicant

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Related Devices (Code: JFY)

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.

K252619QSCHECK UISACRQstag, Inc.K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.K193649Yumizen C1200 Creatinine PAPHORIBA ABX SASK182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.K183555GEM Premier ChemSTATInstrumentation Laboratory COK182038URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzerYd Diagnostics Corporation

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.

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