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510(k) K991473

SIRSCAN by Intelligence Artificielle Applications — Product Code KZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1999
Date Received
April 27, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reader, Zone, Automated
Device Class
Class I
Regulation Number
866.2850
Review Panel
MI
Submission Type

Other clearances for product code KZK

  • K944319 — BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM (December 15, 1994)
  • K932122 — BIOMIC VIDEO PLATE READER (March 1, 1994)