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510(k) K052457

PICSI SPERM SELECTION DEVICE by Biocoat, Inc. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2006
Date Received
September 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

Other clearances by Biocoat, Inc.

  • K032874 — HBA SPERM-HYALURONAN BINDING ASSAY (November 24, 2003)

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