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510(k) K163225

AFIAS iFOB with AFIAS-50 by Immunostics Inc., — Product Code OOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2017
Date Received
November 17, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Occult Blood Analyzer
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

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  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K060463 — HEMA SCREEN SPECIFIC IFOBT (June 6, 2006)
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Other clearances for product code OOX

  • K200754 — Hemosure Accu-Reader A100 (June 2, 2022)
  • K191147 — OC-Auto SENSOR io iFOB Test (January 2, 2020)
  • K132167 — I-CHROMA IFOB WITH I-CHROMA READER (May 2, 2014)
  • K092330 — OC-SENSOR DIANA IFOB TEST (January 8, 2010)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)