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510(k) K050741

IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT by Ind Diagnostic, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2005
Date Received
March 21, 2005
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

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  • K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (December 16, 2005)
  • K052662 — ONE STEP FSH MENOPAUSAL TEST (November 30, 2005)
  • K023638 — CASSETTE/URINE HCG (January 3, 2003)

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