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510(k) K833709

CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK by General Diagnostics — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1983
Date Received
October 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

Other clearances by General Diagnostics

  • K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT (September 19, 1988)
  • K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT (November 3, 1987)
  • K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (June 5, 1987)
  • K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE (March 31, 1987)
  • K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (March 12, 1987)
  • K842307 — GENERAL DIAG. CEFONICID 30MCG ANTIMIC (July 20, 1984)
  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)
  • K830731 — NETILMICIN 30 MCG ANTIMICROBIAL DISK (April 8, 1983)

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