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510(k) K942464

UC QIK 1-STEP HCG TEST by Eucardio Laboratory, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
May 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Eucardio Laboratory, Inc.

  • K926500 — UC QIK PREGNANCY TEST (June 7, 1993)
  • K904137 — UC IMU B (November 21, 1990)
  • K904125 — UC IMU A (September 24, 1990)

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