Home / 510(k) Clearances / K023483

510(k) K023483

KALAZAR DETECT by Inbios Intl., Inc. — Product Code LOO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2003
Date Received
October 17, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Leishmanii Serological
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

Other clearances by Inbios Intl., Inc.

  • DEN100020 — DENV DETECT IGM CAPTURE ELISA (April 8, 2011)
  • K041817 — WEST NILE DETECT IGM ELISA (November 19, 2004)
  • K001092 — GENERIC BLOOD GLUCOSE TEST STRIP (July 26, 2000)
  • K992695 — INSURE PRO TEST (October 18, 1999)
  • K991515 — INSURE PREGNANCY TEST (May 28, 1999)

Other clearances for product code LOO

  • K842526 — AMIZYME-LEISHMANIA SPP. TEST KIT (August 28, 1984)