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510(k) K002359

MDI GLIADIN G TEST by Micro Detect, Inc. — Product Code MST

K002359 is an FDA 510(k) premarket notification submitted by Micro Detect, Inc. for the device "MDI GLIADIN G TEST". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Micro Detect, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2000
Date Received
August 2, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Gliadin
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Micro Detect, Inc.

  • K003794 — ELISA TEST, SEROLOGY (March 30, 2001)
  • K002358 — MDI GLIADIN A TEST (October 19, 2000)
  • K000934 — MDI SCL-70 TEST (April 7, 2000)
  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K994029 — MDI SM TEST (January 11, 2000)
  • K993843 — MDI RF TEST (January 11, 2000)
  • K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN (January 11, 2000)
  • K993635 — MDI SM/RNP TEST (January 10, 2000)
  • K993636 — MDI SS-A TEST (January 10, 2000)
  • K973508 — PYLORI DETECT IGG (March 10, 1998)

Other clearances for product code MST

  • K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Anti (July 28, 2017)
  • K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (December 5, 2013)
  • K113377 — GLIADIN IGA AND GLIADIN LGA (December 14, 2012)
  • K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QU (September 20, 2012)
  • K111414 — QUANTA FLASH (TM) DGP SCREEN (October 20, 2011)
  • K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5 (August 13, 2010)
  • K091522 — IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (February 4, 2010)
  • K083053 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) (August 7, 2009)
  • K083052 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (July 28, 2009)
  • K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (M (October 15, 2008)

FDA data resources