Panels › Hematology › Product code OOX · Class 2
Automated Occult Blood Analyzer
Regulation 864.6550
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OOX
| Company | 510(k)s | Recalls |
|---|---|---|
| Boditech Med, Inc. | 1 | 0 |
| Eiken Chemical Co., Ltd. | 1 | 0 |
| Immunostics Inc., | 1 | 0 |
| Polymedco, Inc. | 1 | 0 |
| Polymedco Cancer Diagnostics, LLC | 1 | 0 |
| W.H.P.M., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2022 | K200754 | Hemosure Accu-Reader A100 W.H.P.M., Inc. | OOX |
| Jan 2, 2020 | K191147 | OC-Auto SENSOR io iFOB Test Eiken Chemical Co., Ltd., JP | OOX |
| Aug 8, 2017 | K163225 | AFIAS iFOB with AFIAS-50 Immunostics Inc., | OOX |
| May 2, 2014 | K132167 | I-CHROMA IFOB WITH I-CHROMA READER Boditech Med, Inc., KR | OOX |
| Jan 8, 2010 | K092330 | OC-SENSOR DIANA IFOB TEST Polymedco Cancer Diagnostics, LLC | OOX |
| Oct 21, 2004 | K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST Polymedco, Inc. | OOX |
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