Polymedco Oc Auto Micro 80 Fob Test
FDA 510(k) K041408 · Polymedco, Inc.
510(k) numberK041408
Submission
- Device name
- Polymedco Oc Auto Micro 80 Fob Test
- Applicant
- Polymedco, Inc.
Cortlandt Manor, NY, US - Received
- May 27, 2004
- Decision date
- October 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
| K092330 | Oc-Sensor Diana Ifob TestOOX · Traditional | Polymedco Cancer Diagnostics, LLC | 01/08/2010SE |
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Questions and answers
When was Polymedco Oc Auto Micro 80 Fob Test cleared by the FDA?
Polymedco Oc Auto Micro 80 Fob Test (K041408) received a 510(k) decision of Substantially Equivalent on October 21, 2004, 147 days after the submission was received.
What is the product code of K041408?
The FDA product code is OOX – Automated Occult Blood Analyzer, a Class II (moderate risk) device regulated under 21 CFR 864.6550.