Home / 510(k) Clearances / K840974

510(k) K840974

SOMAS HUMAN SPINAL FLUID CONTROL by Somas Medical Industries, Inc. — Product Code DFI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
March 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Total Spinal-Fluid, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5860
Review Panel
IM
Submission Type

Other clearances by Somas Medical Industries, Inc.

  • K862179 — SOMAS LIQUID URINE CONTROL (July 1, 1986)
  • K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (July 6, 1984)
  • K840486 — TOTAL BILIRUBIN REAGENT (April 25, 1984)
  • K840485 — TOTAL IRON UIBC/TIBC ASSAY (March 12, 1984)
  • K833787 — SOMAS CHLORIDE ASSAY KIT (January 11, 1984)

Other clearances for product code DFI

  • K854190 — CANTROL SPINAL FLUID CONTROL (November 25, 1985)
  • K843122 — RESOLVE-CSF (November 30, 1984)
  • K832821 — FIAX IGG TEST (October 14, 1983)