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)

ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA

K-Number: K970177 · 1997-06-11

ApplicantImmco Diagnostics, Inc.
Decision Date1997-06-11
Product CodeMID
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-06-11 under 510(k) number K970177. 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 ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA?

ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K970177.

When did ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA receive FDA 510(k) clearance?

ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA received FDA 510(k) clearance on 1997-06-11, under 510(k) number K970177.

Who is the listed applicant for ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA?

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

What is the FDA product code for ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA?

The FDA product code for ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA 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 Immco Diagnostics, 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.

K172745ImmuGlo HEp-2 Elite IFAK172078ImmuLisa Enhanced RNA POL III Antibody ELISAK163133ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAK163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAK151559ImmuLisa Enhanced Centromere Antibody ELISA

View all 53 devices →

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.

↑