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FDA 510(k)

REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT

K-Number: K952287 · 1995-12-18

ApplicantReaads Medical Products, Inc.
Decision Date1995-12-18
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Reaads Medical Products, Inc.. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K952287. The device is classified under product code MID. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT?

REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Reaads Medical Products, Inc.. The 510(k) number is K952287.

When did REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT receive FDA 510(k) clearance?

REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT received FDA 510(k) clearance on 1995-12-18, under 510(k) number K952287.

Who is the listed applicant for REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT?

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

What is the FDA product code for REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT?

The FDA product code for REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT is MID.

Related Clinical Trials

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.

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Other records listing Reaads Medical Products, 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.

K972342REAADS PROTEIN C ANTIGEN TEST KITK972482REAADS PROTEIN S ANTIGEN TEST KITK972005REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT

Related Devices (Code: MID)

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.

K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K130528BIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K113020IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K103834BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad Laboratories

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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