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FDA 510(k)

S40 CREATINE KINASE (CK)

K-Number: K082226 · 2008-09-18

ApplicantAlfa Wassermann Diagnostic Technologies, Inc.
Decision Date2008-09-18
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

S40 CREATINE KINASE (CK) is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2008-09-18 under 510(k) number K082226. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S40 CREATINE KINASE (CK)?

S40 CREATINE KINASE (CK) is a medical device that received FDA 510(k) clearance on 2008-09-18. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K082226.

When did S40 CREATINE KINASE (CK) receive FDA 510(k) clearance?

S40 CREATINE KINASE (CK) received FDA 510(k) clearance on 2008-09-18, under 510(k) number K082226.

Who is the listed applicant for S40 CREATINE KINASE (CK)?

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

What is the FDA product code for S40 CREATINE KINASE (CK)?

The FDA product code for S40 CREATINE KINASE (CK) is JHS.

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Other records listing Alfa Wassermann Diagnostic Technologies, Inc. as applicant

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K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTK123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTK123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULEK122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTK113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTK113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

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Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, Inc.K981495IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)Diagnostic Products Corp.

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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