Automated Occult Blood Analyzer
Hematology · 21 CFR 864.6550
The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
27 firms currently registered for this product code
Eiken Chemical Co., Ltd. Nasu Plant
Ohtawara-shi Tochigi, JP
Eiken Chemical Co., Ltd. Nogi Plant
SHIMOTSUGA-GUN Tochigi, JP
Color Diagnostics, Llc
South San Francisco, CA, US
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, Llc.
CORTLANDT MANOR, NY, US
Saris And Things, Inc.
Plainfield, IL, US
Eiken Chemical Co., Ltd.
Chiyoda-ku Tokyo, JP
Nanbu Plastics Co., Ltd. Fujieda Factory
Fujieda-shi Shizuoka, JP
Peak 5 Packaging Llc
Omaha, NE, US
Boditech Med Inc.
Chuncheon Gangwon, KR
W.h.p.m. Bioresearch & Technology Co., Ltd.
BEIJING, CN
Wellpact
Roaring Spring, PA, US
Home Access Health Corp.
Hoffman Est, IL, US
Kt Tamaseiki Co., Ltd.
Hachiouji Tokyo, JP
Hitachi High-tech Corp., Ome Works
Ome-Shi Tokyo, JP
Previon Solutions Llc
Yorba Linda, CA, US
510(k) clearances
6 clearances for this product code
- W.H.P.M., Inc.Jun 2, 2022
K200754 · Hemosure Accu-Reader A100
- Eiken Chemical Co., Ltd.Jan 2, 2020
K191147 · OC-Auto SENSOR io iFOB Test
- Immunostics Inc.,Aug 8, 2017
K163225 · AFIAS iFOB with AFIAS-50
- Boditech Med, Inc.May 2, 2014
K132167 · I-CHROMA IFOB WITH I-CHROMA READER
- Polymedco Cancer Diagnostics, LLCJan 8, 2010
K092330 · OC-SENSOR DIANA IFOB TEST
- Polymedco, Inc.Oct 21, 2004
K041408 · POLYMEDCO OC AUTO MICRO 80 FOB TEST