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510(k) K832691

BETA SCAN REAGENT STRIP by Orange Medical Instruments, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
August 10, 1983
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 Orange Medical Instruments, Inc.

  • K860808 — CONTINUCATH (March 13, 1986)
  • K851822 — BETA SCAN TRENDS METER (October 3, 1985)
  • K844796 — MICRO-BETA U100 SYRINGE (December 18, 1984)
  • K843882 — TRENDS LANCET (November 5, 1984)
  • K841369 — BETA SCAN DRYSTIX (August 23, 1984)
  • K833705 — BETAJECT BD U100 (May 9, 1984)
  • K833706 — CLICK-COUNT U100 INSULIN SYRINGE (April 5, 1984)
  • K832793 — NEOCATH 1000 W/HEPCOTE (September 26, 1983)
  • K831897 — BETA I PROGRAMMABLE INFUSION PUMP (August 12, 1983)
  • K831523 — BETA SCAN NORMAL CONTROL SOLUTION (July 19, 1983)

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