Home / 510(k) Clearances / K982786

510(k) K982786

TRACCELL 2000 SLIDE MAPPING SYSTEM by Accumed Intl., Inc. — Product Code JOY

K982786 is an FDA 510(k) premarket notification submitted by Accumed Intl., Inc. for the device "TRACCELL 2000 SLIDE MAPPING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Accumed Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1998
Date Received
August 10, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
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)
  • 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)
  • K965190 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE (March 19, 1997)
  • K960366 — SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (April 9, 1996)

Other clearances for product code JOY

  • K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (June 27, 2025)
  • K221309 — AI100 with Shonit (September 19, 2023)
  • K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applicatio (May 3, 2022)
  • K200595 — CellaVision DC-1, CellaVision DC-1 PPA (October 16, 2020)
  • K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application (October 2, 2020)
  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171315 — Advanced RBC Application (August 1, 2017)
  • K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (September 16, 2011)
  • K092116 — EASYCELL CELL LOCATOR (May 12, 2010)
  • K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (November 20, 2009)

FDA data resources