Nephelometer
Immunology · 21 CFR 866.4540
Recent MDR events
35 adverse event reports on file
- ATELLICA NEPH 630Jun 11, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00020
- ATELLICA NEPH 630Feb 5, 2025MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2025-00005
- ATELLICA NEPH 630Jul 24, 2024MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2024-00020
- ATELLICA NEPH 630Jun 21, 2024MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2024-00011
- BN PROSPEC SYSTEMAug 14, 2023MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2023-00011
- BN PROSPEC SYSTEMAug 26, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00047
- BN PROSPEC SYSTEMMay 27, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00039
- ATELLICA NEPH 630 SYSTEMMay 26, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00038
- ATELLICA NEPH 630 SYSTEMApr 29, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00021
- ATELLICA NEPH 630 SYSTEMFeb 21, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00010
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
11 firms currently registered for this product code
Diamond Diagnostics Inc.
Budapest, HU
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Shijiazhuang Hipro Biotechnology Co.,ltd
Shijiazhuang Hebei, CN
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Bit Analytical Solutions Gmbh
SCHWALBACH/TAUNUS Hesse, DE
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
Genrui Biotech Inc
Shenzhen Guangdong, CN
510(k) clearances
11 clearances for this product code
- Dade Behring, Inc.Sep 26, 2000
K001647 · BN PROSPEC SYSTEM
- Behring Diagnostics, Inc.Jun 7, 1990
K761234 · BEHRING LASER NEPHELOMETER
- Behring Diagnostics, Inc.May 4, 1989
K892223 · BEHRING NEPHELOMETER 100
- Unipath , Ltd.Sep 23, 1987
K873401 · TURBOX
- Incstar Corp.Sep 23, 1987
K873407 · RRT SYSTEM LASER REFLECTOMETER ANALYZER
- B C Medical , Ltd.Oct 3, 1980
K801949 · BCM-302 COLLIMATING CONE & COMPENSATIN
- Travenol Laboratories, S.A.Jul 14, 1980
K801391 · DISC 120 TRANSPORTER
- Sherwood Medical IndustriesNov 13, 1979
K792014 · LANCER L-INA BUFFER, POLYMER, WASH SOLU