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FDA 510(k)

MDI GLIADIN A TEST

K-Number: K002358 · 2000-10-19

ApplicantMicro Detect, Inc.
Decision Date2000-10-19
Product CodeMST
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MDI GLIADIN A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Micro Detect, Inc.. It received FDA 510(k) clearance on 2000-10-19 under 510(k) number K002358. 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 MDI GLIADIN A TEST?

MDI GLIADIN A TEST is a medical device that received FDA 510(k) clearance on 2000-10-19. The listed applicant is Micro Detect, Inc.. The 510(k) number is K002358.

When did MDI GLIADIN A TEST receive FDA 510(k) clearance?

MDI GLIADIN A TEST received FDA 510(k) clearance on 2000-10-19, under 510(k) number K002358.

Who is the listed applicant for MDI GLIADIN A TEST?

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

What is the FDA product code for MDI GLIADIN A TEST?

The FDA product code for MDI GLIADIN A TEST is MST.

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Other records listing Micro Detect, 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.

K003794ELISA TEST, SEROLOGYK002359MDI GLIADIN G TESTK000934MDI SCL-70 TESTK000477MDI DS-DNA TESTK993843MDI RF TESTK994029MDI SM TEST

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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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