Ichroma Reader
Catalogue number FPRR001, listed by Boditech MED Inc., South Korea, under Automated Occult Blood Analyzer. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
Record
| Listed by | Boditech MED Inc., South Korea |
|---|---|
| FDA product code | OOX |
| Device type | Automated Occult Blood Analyzer |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2017-10-26 |
| Record revised | 2025-03-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FPRR001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OC-Auto | Polymedco Cancer Diagnostic Products LLC | 727 |
| Fobt-Chek | Polymedco Cancer Diagnostic Products LLC | 5 |
| Color Stool Collection Kit | Color Diagnostics, LLC | 1 |
| Afias iFOB with AFIAS-50 | Boditech MED Inc. | 1 |
| ichroma™ iFOB | Boditech MED Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132167 | 2014-05-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.