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510(k) K912292

DIASTAT ANTI-JO-1 KIT by Shield Diagnostics, Ltd. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
May 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Shield Diagnostics, Ltd.

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  • K982879 — SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (October 15, 1998)
  • K980885 — SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY (August 21, 1998)
  • K972981 — SHIELD HELICO-G2 ELISA KIT (March 17, 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)

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