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FDA 510(k)

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

K-Number: K002189 · 2000-10-19

ApplicantScimedx Corp.
Decision Date2000-10-19
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Corp.. It received FDA 510(k) clearance on 2000-10-19 under 510(k) number K002189. The device is classified under product code MST. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM?

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2000-10-19. The listed applicant is Scimedx Corp.. The 510(k) number is K002189.

When did GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM receive FDA 510(k) clearance?

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM received FDA 510(k) clearance on 2000-10-19, under 510(k) number K002189.

Who is the listed applicant for GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM?

The FDA 510(k) record lists Scimedx Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM?

The FDA product code for GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM is MST.

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Other records listing Scimedx Corp. 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.

K011348PHASE II GBM IGG ANTIBODY EIA TESTK011082TPO IGG ANTIBODY EIA TESTK010625EUROSPITAL EU-TTG IGA UMANAK010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAK010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAK002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

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Related Devices (Code: MST)

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.

K163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAImmco Diagnostics, Inc.K132082AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECKAesku DiagnosticsK113377GLIADIN IGA AND GLIADIN LGAGrifols USA, LLCK113863QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORSInova Diagnostics, Inc.K111414QUANTA FLASH (TM) DGP SCREENInova Diagnostics, Inc.K093459ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01Phadia US, Inc.

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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