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510(k) K972981

SHIELD HELICO-G2 ELISA KIT by Shield Diagnostics, Ltd. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1998
Date Received
August 11, 1997
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 Shield Diagnostics, Ltd.

  • K000398 — SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 (April 17, 2000)
  • K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (October 15, 1998)
  • K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (August 21, 1998)
  • K962825 — SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY (November 15, 1996)
  • K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (November 7, 1996)
  • K961515 — QUANTASE PHENYLALANINE ASSAY (June 12, 1996)
  • K955303 — DIASTAT ANTI-CARDIOLIPIN KIT (May 30, 1996)
  • K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT (June 30, 1995)
  • K952183 — DIASTAT ANTI-THYROGLOBULIN KIT (June 30, 1995)
  • K943630 — DIASTAT ANTI-MPO (PANCA) KIT (March 6, 1995)

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  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
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