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510(k) K844322

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

K844322 is an FDA 510(k) premarket notification submitted by Livonia Diagnostics, Inc. for the device "SGOT REAGENT SET". The FDA issued a decision of Substantially Equivalent on November 27, 1984. The device falls under product code CIQ (Diazo, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Livonia Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K843895 — TOTAL CALCIUM REAGENT SET (October 30, 1984)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K843893 — MAGNESIUM 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)

FDA data resources