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510(k) K161947

Chagas Detect Plus Rapid Test by InBios International, Inc. — Product Code MIU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2016
Date Received
July 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

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Other clearances for product code MIU

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  • K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (February 11, 2004)
  • K930272 — HEMAGEN CHAGAS' KIT (EIA METHOD) (May 19, 1995)
  • K933716 — ABBOTT CHAGAS ANTIBODY EIA (December 19, 1994)
  • K911233 — CHAGAS' IGG ELISA TEST (May 4, 1992)