The following data is part of a premarket notification filed by Boditech Med Inc. with the FDA for I-chroma Ifob With I-chroma Reader.
| Device ID | K132167 |
| 510k Number | K132167 |
| Device Name: | I-CHROMA IFOB WITH I-CHROMA READER |
| Classification | Automated Occult Blood Analyzer |
| Applicant | Boditech Med Inc. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON Chuncheon-si, Gang-won-do, KR 200-883 |
| Contact | Sang Yeol Park |
| Correspondent | Sang Yeol Park Boditech Med Inc. 43, GEODUDANJI 1-GIL, DONGNAE-MYEON Chuncheon-si, Gang-won-do, KR 200-883 |
| Product Code | OOX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-12 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806679002718 | K132167 | 000 |