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510(k) K853684

PRECEPT KANAMYCIN by Austin Biological Laboratories — Product Code LTW

K853684 is an FDA 510(k) premarket notification submitted by Austin Biological Laboratories for the device "PRECEPT KANAMYCIN". The FDA issued a decision of Substantially Equivalent on September 13, 1985. The device falls under product code LTW (Susceptibility Test Cards, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Austin Biological Laboratories has at least 10 other 510(k) clearances on record.

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

  • K880511 — XACT NEISSERIA (August 25, 1988)
  • K874727 — PRECEPT(TM) CIPROFLOXACIN (February 18, 1988)
  • K870769 — AUSTIN NONFERMENTER KIT (April 3, 1987)
  • K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID (November 13, 1986)
  • K862446 — PRECEPT CEFTAZIDIME (July 11, 1986)
  • K862560 — PRECEPT CEFTIZOXIME (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)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)

Other clearances for product code LTW

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

FDA data resources