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510(k) K992695

INSURE PRO TEST by Inbios Intl., Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1999
Date Received
August 11, 1999
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 Inbios Intl., Inc.

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  • K041817 — WEST NILE DETECT IGM ELISA (November 19, 2004)
  • K023483 — KALAZAR DETECT (May 6, 2003)
  • K001092 — GENERIC BLOOD GLUCOSE TEST STRIP (July 26, 2000)
  • K991515 — INSURE PREGNANCY TEST (May 28, 1999)

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