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FDA 510(k)

S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022

K-Number: K091333 · 2009-08-03

ApplicantAlfa Wassermann, Inc.
Decision Date2009-08-03
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 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 2009-08-03 under 510(k) number K091333. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022?

S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 is a medical device that received FDA 510(k) clearance on 2009-08-03. The listed applicant is Alfa Wassermann, Inc.. The 510(k) number is K091333.

When did S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 receive FDA 510(k) clearance?

S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 received FDA 510(k) clearance on 2009-08-03, under 510(k) number K091333.

Who is the listed applicant for S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022?

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 LDL CHOLESTEROL (LDL), MODEL RC0022?

The FDA product code for S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 is MRR.

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Other records listing Alfa Wassermann, Inc. 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.

K091413S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017K080073S-TEST CREATININE (CRE)K063306ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72

Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcienceK051121DIRECT LDL CHOLESTEROL, MODEL L530-60HTeco Diagnostics

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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