Decision Date2008-06-26
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
S-TEST C02 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 2008-06-26 under 510(k) number K073223. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the S-TEST C02?
S-TEST C02 is a medical device that received FDA 510(k) clearance on 2008-06-26. The listed applicant is Alfa Wassermann Diagnostic Technologies, Inc.. The 510(k) number is K073223.
When did S-TEST C02 receive FDA 510(k) clearance?
S-TEST C02 received FDA 510(k) clearance on 2008-06-26, under 510(k) number K073223.
Who is the listed applicant for S-TEST C02?
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 S-TEST C02?
The FDA product code for S-TEST C02 is KHS.
Other records listing Alfa Wassermann Diagnostic Technologies, Inc. as applicant
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Related Devices (Code: KHS)
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K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann
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.