Oc-Sensor Diana Ifob Test
FDA 510(k) K092330 · Polymedco Cancer Diagnostics, LLC
510(k) numberK092330
Submission
- Device name
- Oc-Sensor Diana Ifob Test
- Applicant
- Polymedco Cancer Diagnostics, LLC
Cortlandt Manor, NY, US - Received
- August 4, 2009
- Decision date
- January 8, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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 |
| K132167 | I-Chroma Ifob with I-Chroma ReaderOOX · Traditional | Boditech Med, Inc. | 05/02/2014SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | Polymedco, Inc. | 10/21/2004SE |
Questions and answers
When was Oc-Sensor Diana Ifob Test cleared by the FDA?
Oc-Sensor Diana Ifob Test (K092330) received a 510(k) decision of Substantially Equivalent on January 8, 2010, 157 days after the submission was received.
What is the product code of K092330?
The FDA product code is OOX – Automated Occult Blood Analyzer, a Class II (moderate risk) device regulated under 21 CFR 864.6550.