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510(k) K842134

SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY by Somas Medical Industries, Inc. — Product Code JGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
May 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric, Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Somas Medical Industries, Inc.

  • K862179 — SOMAS LIQUID URINE CONTROL (July 1, 1986)
  • 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)
  • K833787 — SOMAS CHLORIDE ASSAY KIT (January 11, 1984)

Other clearances for product code JGQ

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  • K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (October 19, 2007)
  • K071239 — TOTAL PROTEIN URINE/CSF GEN.3 (September 14, 2007)
  • K981295 — UPRO (October 1, 1998)
  • K981682 — UPRO (September 21, 1998)
  • K925794 — TRACE MICROPROTEIN REAGENT (March 29, 1993)
  • K913615 — URINARY/CSF PROTEIN (September 13, 1991)
  • K903914 — PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (October 3, 1990)
  • K901083 — EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (April 16, 1990)
  • K863478 — CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (October 29, 1986)