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510(k) K843528

GLUCOSE OXIDASE ENZYMATIC REAGENT SET by Livonia Diagnostics, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1984
Date Received
September 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Livonia Diagnostics, Inc.

  • K852161 — SERUM IRON/VIBC REAGENT SET (June 10, 1985)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • 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)
  • K844024 — CREATININE REAGENT SET (October 30, 1984)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K843893 — MAGNESIUM REAGENT SET (October 30, 1984)

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