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FDA 510(k)

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017

K-Number: K091544 · 2009-09-09

ApplicantAlfa Wassermann, Inc.
Decision Date2009-09-09
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 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 2009-09-09 under 510(k) number K091544. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017?

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 is a medical device that received FDA 510(k) clearance on 2009-09-09. The listed applicant is Alfa Wassermann, Inc.. The 510(k) number is K091544.

When did S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 receive FDA 510(k) clearance?

S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 received FDA 510(k) clearance on 2009-09-09, under 510(k) number K091544.

Who is the listed applicant for S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017?

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 LACTATE DEHYDROGENASE (LD), MODEL RC 0017?

The FDA product code for S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 is CFJ.

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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)K091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022K080073S-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: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.K971398LD-L REAGENTCarolina Liquid Chemistries 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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