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510(k) K854260

CHEMPRO 1000 by Sen Tech Medical Corp. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1985
Date Received
October 23, 1985
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 Sen Tech Medical Corp.

  • K910071 — PORTA GAS COMPRESSED GAS CYLINDER CART (March 22, 1991)
  • K855091 — CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (March 14, 1986)
  • K851100 — CHEM PRO 1000 CHEMISTRY ANALYSIS (July 9, 1985)
  • K841575 — SENTECH'S ULAB 1000 CLINICAL CHEM. (July 6, 1984)

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