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510(k) K132167

I-CHROMA IFOB WITH I-CHROMA READER by Boditech Med, Inc. — Product Code OOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2014
Date Received
July 12, 2013
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.

Other clearances by Boditech Med, Inc.

  • K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (October 13, 2017)

Other clearances for product code OOX

  • K200754 — Hemosure Accu-Reader A100 (June 2, 2022)
  • K191147 — OC-Auto SENSOR io iFOB Test (January 2, 2020)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K092330 — OC-SENSOR DIANA IFOB TEST (January 8, 2010)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)