Calibrator, Surrogate
Clinical Chemistry · 21 CFR 862.1150
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
8 firms currently registered for this product code
Sysmex Corporation
KOBE Hyogo, JP
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Arkray Industry Inc.
Sto. Tomas Batangas, PH
Sysmex Corporation Techno Park
KOBE Hyogo, JP
Benson Viscometers Ltd
Haverfordwest Pembrokeshire, GB
Sysmex Corporation Seishin Factory
Kobe Hyogo, JP
Chaptec America
Montreal Quebec, CA
Sysmex America, Inc.
Lincolnshire, IL, US
510(k) clearances
17 clearances for this product code
- Wako Chemicals USA, Inc.Sep 25, 1997
K973055 · WAKO CH50 LINEARITY SET
- Dade Chemistry Systems, Inc.Feb 20, 1997
K970396 · HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
- Sigma Diagnostics, Inc.Apr 3, 1991
K910255 · FLOW CYTOMETRY FITC/PE COMPENSATION KIT
- Diagnostic Products Corp.Oct 4, 1990
K902575 · SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
- Sigma Chemical Co.Jul 3, 1990
K902294 · ACCUSCAN MICROBEAD STANDARDS
- Analytical Control Systems, Inc.Jun 21, 1989
K892213 · ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
- Reagents Applications, Inc.Dec 14, 1988
K883389 · RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
- King Diagnostics, Inc.Aug 2, 1988
K882220 · CALIBRATION KIT