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510(k) K833787

SOMAS CHLORIDE ASSAY KIT by Somas Medical Industries, Inc.

K833787 is an FDA 510(k) premarket notification submitted by Somas Medical Industries, Inc. for the device "SOMAS CHLORIDE ASSAY KIT". The FDA issued a decision of Substantially Equivalent on January 11, 1984. Somas Medical Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1984
Date Received
October 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K840974 — SOMAS HUMAN SPINAL FLUID CONTROL (April 5, 1984)
  • K840485 — TOTAL IRON UIBC/TIBC ASSAY (March 12, 1984)

FDA data resources