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510(k) K844322

SGOT REAGENT SET by Livonia Diagnostics, Inc. — Product Code CIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1984
Date Received
November 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

Other clearances by Livonia Diagnostics, Inc.

  • K852161 — SERUM IRON/VIBC REAGENT SET (June 10, 1985)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K844237 — ALKALINE PHOSPHATASE REAGENT SET (November 20, 1984)
  • K844156 — UREA NITROGEN REAGENT SET (November 13, 1984)
  • K844182 — INORGANIC PHOSPHORUS REAGENT SET (November 9, 1984)
  • K843894 — HDL PRECIPATATING REAGENT SET (November 2, 1984)
  • K843893 — MAGNESIUM REAGENT SET (October 30, 1984)
  • K843895 — TOTAL CALCIUM REAGENT SET (October 30, 1984)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K844024 — CREATININE REAGENT SET (October 30, 1984)

Other clearances for product code CIQ

  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)
  • K860216 — SGOT (AST) REAGENT SET (April 3, 1986)
  • K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (January 14, 1986)
  • K841065 — SGOT REAGENT SET (May 1, 1984)
  • K821209 — SGOT REAGENT SET (July 14, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)