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510(k) K964689

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
November 22, 1996
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

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  • K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN (December 14, 1998)
  • K983301 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN (November 25, 1998)
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  • K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (January 22, 1998)
  • 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)

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