OC-Auto OC802
by Polymedco Cancer Diagnostic Products LLC
OC-Auto OC802 is a Class II device made by Polymedco Cancer Diagnostic Products LLC, cleared under FDA 510(k) K041408 on 21 Oct 2004 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00855574005544), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00855574005544 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041408 | Date21 Oct 2004 | StatusActive |
Official records
- AccessGUDID record 00855574005544
- FDA 510(k) database K041408
Across registries
- FDA 510(k) K041408 decided 21 Oct 2004 Active
- FDA GUDID UDI-DI 00855574005544 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K041408
- Listed FDA GUDID 00855574005544
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OC-Auto
- Generic name
- Faecal occult blood IVD, reagent
- Model / reference
- OC802
- Description
- Latex Reagent for OC-Auto Micro 80 iFOB 2 x 4 mL
- Primary DI / UDI-DI
- 00855574005544
- 510(k) Number
- FDA product code
- OOX
- GMDN term
- Faecal occult blood IVD, reagent
- Device class
- Class II
- Regulation number
- 864.6550
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OOX (Automated Occult Blood Analyzer).
- OC-Auto SENSOR io iFOB Test by EIKEN CHEMICAL CO., LTD.
- OC-SENSOR DIANA IFOB TEST by Polymedco Cancer Diagnostics, LLC
- POLYMEDCO OC AUTO MICRO 80 FOB TEST by POLYMEDCO, INC.
- AFIAS iFOB with AFIAS-50 by IMMUNOSTICS, INC.
- Hemosure Accu-Reader A100 by W.H.P.M. INC.
- I-CHROMA IFOB WITH I-CHROMA READER by Boditech Med, Inc.
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