Data / Medical devices / Automated Occult Blood Analyzer
Automated Occult Blood Analyzer (OOX): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Automated Occult Blood Analyzer (product code OOX, Class 2, 21 CFR 864.6550). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on June 2, 2022, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OOX
- Device class
- 2
- Regulation
- 864.6550
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| Japan | 6 |
| United States | 2 |
| China | 1 |
| South Korea | 1 |
Makers of Automated Occult Blood Analyzer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Eiken Chemical Co., Ltd. | Chiyoda-ku Tokyo, Japan | Specification developer | 3 | January 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Eiken Chemical Co., Ltd. Nogi Plant | SHIMOTSUGA-GUN Tochigi, Japan | Manufacturer | 3 | January 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Eiken Chemical Co., Ltd. Nasu Plant | Ohtawara-shi Tochigi, Japan | Manufacturer | 3 | January 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Color Diagnostics, LLC | South San Francisco, CA, United States | Specification developer | 1 | January 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| W.H.P.M. Bioresearch & Technology Co., Ltd. | Beijing, China | Manufacturer | 1 | June 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boditech Med Inc. | Chuncheon Gangwon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HITACHI HIGH-TECH CORP., Ome Works | Ome-Shi Tokyo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KT Tamaseiki Co., Ltd. | Hachiouji Tokyo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanbu Plastics Co., Ltd. Fujieda Factory | Fujieda-shi Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peak 5 Packaging LLC | Omaha, NE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 2, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.