I-Chroma Ifob with I-Chroma Reader
FDA 510(k) K132167 · Boditech Med, Inc.
510(k) numberK132167
Submission
- Device name
- I-Chroma Ifob with I-Chroma Reader
- Applicant
- Boditech Med, Inc.
Chuncheon-Si, Gang-Won-Do, KR - Received
- July 12, 2013
- Decision date
- May 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOX – Automated Occult Blood Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Specialty
- Hematology
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 510(k)s with product code OOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100OOX · Traditional | W.H.P.M., Inc. | 06/02/2022SE |
| K191147 | OC-Auto SENSOR io iFOB TestOOX · Traditional | Eiken Chemical Co., Ltd. | 01/02/2020SE |
| K163225 | AFIAS iFOB with AFIAS-50OOX · Traditional | Immunostics Inc., | 08/08/2017SE |
| K092330 | Oc-Sensor Diana Ifob TestOOX · Traditional | Polymedco Cancer Diagnostics, LLC | 01/08/2010SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | Polymedco, Inc. | 10/21/2004SE |
More from Polymedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLW · Traditional | 10/13/2017SE |
Questions and answers
When was I-Chroma Ifob with I-Chroma Reader cleared by the FDA?
I-Chroma Ifob with I-Chroma Reader (K132167) received a 510(k) decision of Substantially Equivalent on May 2, 2014, 294 days after the submission was received.
What is the product code of K132167?
The FDA product code is OOX – Automated Occult Blood Analyzer, a Class II (moderate risk) device regulated under 21 CFR 864.6550.