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510(k) K882192

HYGEIA URINE PREGNANCY TEST by Hygeia Sciences — Product Code DHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1988
Date Received
May 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Hygeia Sciences

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  • K862083 — HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY (July 2, 1986)
  • K862133 — HYGEIA RAPID STREP A TEST (June 25, 1986)

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