AFIAS iFOB with AFIAS-50
FDA 510(k) clearance K163225 · decided 2017-08-08
Clearance details
- K-number
- K163225
- Device name
- AFIAS iFOB with AFIAS-50
- Applicant
- Immunostics Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2016-11-17
- Decision date
- 2017-08-08
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- OOX
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ocean, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Hemosure Accu-Reader A100 (K200754) | W.H.P.M., Inc. | 2022-06-02 |
| OC-Auto SENSOR io iFOB Test (K191147) | Eiken Chemical Co., Ltd. | 2020-01-02 |
| I-CHROMA IFOB WITH I-CHROMA READER (K132167) | Boditech Med, Inc. | 2014-05-02 |
| OC-SENSOR DIANA IFOB TEST (K092330) | Polymedco Cancer Diagnostics, LLC | 2010-01-08 |
| POLYMEDCO OC AUTO MICRO 80 FOB TEST (K041408) | Polymedco, Inc. | 2004-10-21 |
Recalls involving this device
No recalls on record reference this clearance.