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510(k) K860031

GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK by Organon Teknika Corp. — Product Code JTT

K860031 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK". The FDA issued a decision of Substantially Equivalent on Mar 6, 1986. The device falls under product code JTT (Susceptibility Test Powders, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Organon Teknika Corp. has 129 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 6, 1986
Date Received
Jan 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Susceptibility Test Powders, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type
510(k)

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (Oct 20, 2000)
  • K000492 — MDA D-DIMER (Jun 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (Mar 2, 2000)
  • K994343 — BACT/ALERT SV (Feb 10, 2000)
  • K993423 — BACT/ALERT SA (Dec 15, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (Dec 14, 1999)
  • K993421 — BACT/ALERT SN (Dec 14, 1999)
  • K992432 — BACT/ALERT FN (Sep 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (Sep 15, 1999)
  • K992400 — BACTALERT FA (Sep 3, 1999)

Other clearances for product code JTT

  • K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (Dec 17, 1998)
  • K935805 — PASCO MIC AND MIC/ID PANELS (Jun 13, 1994)
  • K895362 — BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST (Dec 1, 1989)
  • K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDER (May 4, 1988)
  • K872081 — CIPRO (TM) DIAGNOSTIC POWDER (Jun 15, 1987)
  • K864442 — NORFLOXACIN SUSCEPTIBILITY POWDER (Dec 11, 1986)
  • K855207 — IMIPENEM 10 MCG SENSITIVITY DISCS (Mar 6, 1986)
  • K855106 — IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (Mar 6, 1986)
  • K855071 — IMIPENEM SUSCEPTIBILITY POWDER (Mar 6, 1986)
  • K830758 — AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (May 25, 1983)

FDA data resources

Source: FDA 510(k) database entry for K860031. Report a data issue: hello@regdatalab.com.