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FDA 510(k)

ANALYST PANELS + ANALYTICAL TEST ROTOR

K-Number: K010864 · 2001-05-21

ApplicantHemagen Diagnostics, Inc.
Decision Date2001-05-21
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYST PANELS + ANALYTICAL TEST ROTOR is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-05-21 under 510(k) number K010864. 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 ANALYST PANELS + ANALYTICAL TEST ROTOR?

ANALYST PANELS + ANALYTICAL TEST ROTOR is a medical device that received FDA 510(k) clearance on 2001-05-21. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K010864.

When did ANALYST PANELS + ANALYTICAL TEST ROTOR receive FDA 510(k) clearance?

ANALYST PANELS + ANALYTICAL TEST ROTOR received FDA 510(k) clearance on 2001-05-21, under 510(k) number K010864.

Who is the listed applicant for ANALYST PANELS + ANALYTICAL TEST ROTOR?

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

What is the FDA product code for ANALYST PANELS + ANALYTICAL TEST ROTOR?

The FDA product code for ANALYST PANELS + ANALYTICAL TEST ROTOR is KHS.

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Related Devices (Code: KHS)

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.

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.

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