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510(k) K861159

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

K861159 is an FDA 510(k) premarket notification submitted by Ramco Laboratories, Inc. for the device "SPECTRO VWF". The FDA issued a decision of Substantially Equivalent on May 1, 1986. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Ramco Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1986
Date Received
March 28, 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)
  • K864701 — VWF IMMUNOBLOT (March 30, 1987)
  • 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

  • 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