Submission Details
| 510(k) Number | K092330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 04, 2009 |
| Decision Date | January 08, 2010 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
Cleared
Traditional
OC-SENSOR DIANA IFOB TEST
Jan 2010
Decision
157d
Days
Class 2
Risk
About This 510(k) Submission
K092330 is an FDA 510(k) clearance for the OC-SENSOR DIANA IFOB TEST, a Automated Occult Blood Analyzer (Class II — Special Controls, product code OOX), submitted by Polymedco Cancer Diagnostics, LLC (Cortlandt Manor, US). The FDA issued a Cleared decision on January 8, 2010, 157 days after receiving the submission on August 4, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.
Device Classification
| Product Code | OOX — Automated Occult Blood Analyzer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
| Definition | 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. |
Manufacturer
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