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510(k) K864701

VWF IMMUNOBLOT by Ramco Laboratories, Inc. — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
December 2, 1986
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 Ramco Laboratories, Inc.

  • K983107 — VFE (October 22, 1998)
  • K981208 — TFR (October 21, 1998)
  • K910481 — EPO-RIA (November 29, 1991)
  • K872941 — SPECTRO C (September 4, 1987)
  • K861159 — SPECTRO VWF (May 1, 1986)
  • K831470 — PTH MR (June 22, 1983)
  • K823016 — CANDIDA DETECTION SYSTEM (December 28, 1982)
  • K812056 — SPECTRO FEIRITIN (August 12, 1981)

Other clearances for product code GGP

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  • 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)