Home / 510(k) Clearances / K965190

510(k) K965190

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE by Accumed Intl., Inc. — Product Code JWY

K965190 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Accumed Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1997
Date Received
December 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Accumed Intl., Inc.

  • K984489 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (February 16, 1999)
  • K983306 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN (December 18, 1998)
  • K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (December 17, 1998)
  • K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN (December 14, 1998)
  • K983301 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN (November 25, 1998)
  • K982786 — TRACCELL 2000 SLIDE MAPPING SYSTEM (October 16, 1998)
  • K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (January 22, 1998)
  • K964689 — TRACCELL 2000 SLIDE MAPPING SYSTEM (August 18, 1997)
  • K972756 — MODIFICATION OF EST CULTURE SYSTEM II - MYCO (August 1, 1997)
  • K960366 — SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (April 9, 1996)

Other clearances for product code JWY

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)

FDA data resources