510(k) K132167
- Device
- I-CHROMA IFOB WITH I-CHROMA READER
- Applicant
- Boditech Med Inc.
- 510(k) number
- K132167
- Product code
- OOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-02
- Date received
- 2013-07-12
- Regulation
- 864.6550
- Classification name
- Automated Occult Blood Analyzer
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SANG YEOL PARK
- Address
- 43, Geodudanji 1-Gil, Dongnae-Myeon Chuncheon-Si, Gang-Won-Do KR 200-883 200-883
FDA Registration Numbers#
- 9611917
- 3010391795
- 3011845225
- 3010392456
- 3005610352
- 3007114058
- 3005345870
- 3013652330
- 3012598266
- 3020710668
- 9610865
- 3017923561
- 1423455
- 3009491259
- 3030896267
- 2435505
Source Documents#
Other 510(k) Records For Product Code OOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | 2022-06-02 |
| K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | 2020-01-02 |
| K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | 2017-08-08 |
| K092330 | OC-SENSOR DIANA IFOB TEST | Polymedco Cancer Diagnostics, LLC | 2010-01-08 |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | Polymedco, Inc. | 2004-10-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary