Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

READS(R) IGA ANTI-CARDIOLIPIN TEST KIT

K-Number: K914405 · 1991-12-18

ApplicantReads Medical Products, Inc.
Decision Date1991-12-18
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

READS(R) IGA ANTI-CARDIOLIPIN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Reads Medical Products, Inc.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K914405. 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 READS(R) IGA ANTI-CARDIOLIPIN TEST KIT?

READS(R) IGA ANTI-CARDIOLIPIN TEST KIT is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Reads Medical Products, Inc.. The 510(k) number is K914405.

When did READS(R) IGA ANTI-CARDIOLIPIN TEST KIT receive FDA 510(k) clearance?

READS(R) IGA ANTI-CARDIOLIPIN TEST KIT received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914405.

Who is the listed applicant for READS(R) IGA ANTI-CARDIOLIPIN TEST KIT?

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

What is the FDA product code for READS(R) IGA ANTI-CARDIOLIPIN TEST KIT?

The FDA product code for READS(R) IGA ANTI-CARDIOLIPIN 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Reads 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.

K914853ANTINUCLEAR ANTIBODY (ANA) SCREENING 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑