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510(k) K840114

COAGULATION FACTOR DEFICIENT PLASMA by Medical Specialties Laboratories — Product Code GGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 11, 1984
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 Medical Specialties Laboratories

  • K852643 — UNI-PLATE (August 8, 1985)
  • K844897 — HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8 (March 22, 1985)
  • K823587 — UNI-CELL (January 5, 1983)
  • K810268 — NORMLCERA (March 6, 1981)

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  • 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)