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510(k) K003794

ELISA TEST, SEROLOGY by Micro Detect, Inc. — Product Code LYR

K003794 is an FDA 510(k) premarket notification submitted by Micro Detect, Inc. for the device "ELISA TEST, SEROLOGY". The FDA issued a decision of Substantially Equivalent on March 30, 2001. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Micro Detect, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2001
Date Received
December 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Micro Detect, Inc.

  • K002358 — MDI GLIADIN A TEST (October 19, 2000)
  • K002359 — MDI GLIADIN G 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)
  • K993971 — MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN (January 11, 2000)
  • K993843 — MDI RF TEST (January 11, 2000)
  • K993636 — MDI SS-A TEST (January 10, 2000)
  • K993635 — MDI SM/RNP TEST (January 10, 2000)
  • K973508 — PYLORI DETECT IGG (March 10, 1998)

Other clearances for product code LYR

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • K183573 — Vstrip H. pylori Antigen Rapid Test (March 14, 2019)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)

FDA data resources