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510(k) K840974

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

K840974 is an FDA 510(k) premarket notification submitted by Somas Medical Industries, Inc. for the device "SOMAS HUMAN SPINAL FLUID CONTROL". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code DFI (Total Spinal-Fluid, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5860. Somas Medical Industries, Inc. has at least 5 other 510(k) clearances on record.

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)

FDA data resources