Stanbio Laboratory, LP
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 47
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0490-2024 | Class II | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood | October 2, 2023 |
| Z-0905-2022 | Class II | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | March 16, 2022 |
| Z-2202-2021 | Class III | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | July 12, 2021 |
| Z-2201-2021 | Class III | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. | July 12, 2021 |
| Z-2200-2021 | Class III | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. | July 12, 2021 |
| Z-2203-2021 | Class III | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent. | July 12, 2021 |
| Z-2199-2021 | Class III | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | July 12, 2021 |
| Z-1070-2018 | Class II | RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 1732 | February 13, 2018 |
| Z-2926-2018 | Class II | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label | February 8, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | June 10, 2009 |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | July 18, 2008 |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | June 30, 2005 |
| K050283 | CREATININE LIQUICOLOR | June 30, 2005 |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | March 14, 2005 |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | October 14, 2004 |
| K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR | March 12, 2004 |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | March 10, 2004 |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | October 24, 2003 |
| K020378 | QUPID PLUS E.R. | June 21, 2002 |
| K974429 | RAPET CRP | February 18, 1998 |
| K974370 | RAPET RF | February 17, 1998 |
| K972155 | CREATINE KINASE (CK) | July 17, 1997 |
| K962418 | UREA NITROGEN (BUN) LIQUI-UV | December 26, 1996 |
| K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET | July 20, 1994 |
| K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET | July 14, 1994 |
| K941313 | STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET | May 17, 1994 |
| K932049 | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 | November 16, 1993 |
| K902204 | STANBIO CSF/URINE TOTAL PROTEIN TEST SET | August 22, 1990 |
| K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | July 25, 1989 |