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510(k) K962825

SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY by Shield Diagnostics, Ltd. — Product Code GGP

K962825 is an FDA 510(k) premarket notification submitted by Shield Diagnostics, Ltd. for the device "SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY". The FDA issued a decision of Substantially Equivalent on November 15, 1996. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1996
Date Received
July 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
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)
  • K972981 — SHIELD HELICO-G2 ELISA KIT (March 17, 1998)
  • 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)
  • K952183 — DIASTAT ANTI-THYROGLOBULIN KIT (June 30, 1995)
  • K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT (June 30, 1995)
  • K943630 — DIASTAT ANTI-MPO (PANCA) KIT (March 6, 1995)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)

FDA data resources