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510(k) K853684

PRECEPT KANAMYCIN by Austin Biological Laboratories — Product Code LTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1985
Date Received
March 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Cards, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Austin Biological Laboratories

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  • K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID (November 13, 1986)
  • K862560 — PRECEPT CEFTIZOXIME (July 11, 1986)
  • K862446 — PRECEPT CEFTAZIDIME (July 11, 1986)
  • K860194 — AUSTIN ENTERIC SYSTEM (February 20, 1986)
  • K860195 — PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE (February 20, 1986)
  • K854577 — PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) (February 5, 1986)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)

Other clearances for product code LTW

  • K852613 — MIC-CONCEPT SYSTEM (September 20, 1985)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)
  • K853273 — PRECEPT CEFTRIAXONE (September 16, 1985)
  • K853596 — PRECEPT CEFOPERAZONE (September 16, 1985)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)
  • K853686 — PRECEPT TM AMIKACIN (September 13, 1985)
  • K853689 — PRECEPT TM MOXALACTAM (September 13, 1985)
  • K853687 — PRECEPT NETILMICIN 32-13 (September 13, 1985)
  • K853688 — PRECEPT TM TOBRAMYCIN (September 13, 1985)
  • K853263 — PRECEPT AVGMENTIN (August 29, 1985)