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510(k) K812994

MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK by General Diagnostics — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1981
Date Received
October 26, 1981
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

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  • 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)
  • K833709 — CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK (December 30, 1983)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)

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