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510(k) K944319

BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM by Giles Scientific, Inc. — Product Code KZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
September 2, 1994
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 by Giles Scientific, Inc.

  • K932122 — BIOMIC VIDEO PLATE READER (March 1, 1994)
  • K854521 — BIOGRAM (December 23, 1985)
  • K843725 — BIOGRAM (May 21, 1985)

Other clearances for product code KZK

  • K991473 — SIRSCAN (November 23, 1999)
  • K932122 — BIOMIC VIDEO PLATE READER (March 1, 1994)