Company ยท US
Stanbio Laboratory
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2009. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 6 |
| GKR | System, Hemoglobin, Automated | 4 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 4 |
| LBR | Ldl & Vldl Precipitation, Hdl | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 |
| LDP | Colorimetry, Acetaminophen | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDL | Berthelot Indophenol, Urea Nitrogen | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIO | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2009 | K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory | GKR |
| Jul 18, 2008 | K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory | GKR |
| Jun 30, 2005 | K050283 | CREATININE LIQUICOLOR Stanbio Laboratory | JFY |
| Jun 30, 2005 | K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR Stanbio Laboratory | JFM |
| Mar 14, 2005 | K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER Stanbio Laboratory | JJE |
| Oct 14, 2004 | K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY Stanbio Laboratory | DCK |
| Mar 12, 2004 | K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR Stanbio Laboratory | JIX |
| Mar 10, 2004 | K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR Stanbio Laboratory | LBS |
| Oct 24, 2003 | K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM Stanbio Laboratory | GKR |
| Jun 21, 2002 | K020378 | QUPID PLUS E.R. Stanbio Laboratory | JHI |
| Feb 18, 1998 | K974429 | RAPET CRP Stanbio Laboratory | DCN |
| Feb 17, 1998 | K974370 | RAPET RF Stanbio Laboratory | DHR |
| Jul 17, 1997 | K972155 | CREATINE KINASE (CK) Stanbio Laboratory | CGS |
| Dec 26, 1996 | K962418 | UREA NITROGEN (BUN) LIQUI-UV Stanbio Laboratory | CDQ |
| Jul 20, 1994 | K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET Stanbio Laboratory | CKA |
| Jul 14, 1994 | K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET Stanbio Laboratory | JQB |
| May 17, 1994 | K941313 | STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET Stanbio Laboratory | CJE |
| Nov 16, 1993 | K932049 | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 Stanbio Laboratory | CIT |
| Aug 22, 1990 | K902204 | STANBIO CSF/URINE TOTAL PROTEIN TEST SET Stanbio Laboratory | JIR |
| Jul 25, 1989 | K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 Stanbio Laboratory | CDL |
| Feb 7, 1989 | K883170 | STANBIO MAGNESIUM TEST SET, CAT. NO 0130 Stanbio Laboratory | JGJ |
| May 23, 1988 | K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 Stanbio Laboratory | GMQ |
| Mar 24, 1988 | K880467 | STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR Stanbio Laboratory | JIY |
| Jun 1, 1987 | K870746 | STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 Stanbio Laboratory | JFJ |
| Apr 17, 1985 | K851278 | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 Stanbio Laboratory | LDP |
| Sep 21, 1984 | K842544 | STANBIO QUICK-TELL MONOCLONAL INDIRECT Stanbio Laboratory | JHJ |
| Feb 3, 1984 | K832867 | FERTITUBE PREGNANCY TEST #1120 Stanbio Laboratory | JHJ |
| Oct 4, 1983 | K832640 | QUICK-TELL INDIRECT PREGNANCY TEST Stanbio Laboratory | JHJ |
| Sep 12, 1983 | K832557 | FERTITELL DIRECT PREGNANCY TEST #1100 Stanbio Laboratory | JHJ |
| Aug 31, 1983 | K832444 | ENZYMATIC TRIGLYCERIDES #2000 Stanbio Laboratory | CDT |
| Aug 16, 1983 | K832159 | UNITIZED ENZYMATIC GLUCOSE TEST SET Stanbio Laboratory | CGA |
| Jul 22, 1983 | K831864 | URIC-ACID TEST ENZYMATIC COLORIMETRIC Stanbio Laboratory | KNK |
| Jul 22, 1983 | K831863 | CHOLESTEROL-ENZYMATIC REAGENT SET Stanbio Laboratory | CHH |
| Jul 22, 1983 | K831858 | TRIGLYCERIDES REAGENT SET Stanbio Laboratory | CDT |
| Nov 29, 1982 | K823237 | BARBITURATE TEST SET #0550-050 Stanbio Laboratory | DJN |
| Dec 22, 1981 | K813349 | BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL Stanbio Laboratory | DIF |
| Feb 2, 1981 | K810055 | STANBIO BILIRUBIN TEST SET Stanbio Laboratory | CIG |
| Jun 20, 1980 | K801014 | STANBIO ACETAMINOPHEN TEST SET #0850 Stanbio Laboratory | LDP |
| Apr 16, 1980 | K800693 | STANBIO PROSTATIC ACID PHOSPHATASE TEST Stanbio Laboratory | CKE |
| Feb 13, 1980 | K800190 | STANBIO DIRECT URIC ACID TEST SET #0770 Stanbio Laboratory | CDH |
| Dec 4, 1978 | K781865 | IRON BINDING CAPICITY MODEL 0370 Stanbio Laboratory | JIY |
| Oct 3, 1978 | K781635 | CHLORIDE TEST SET, CAT.# 0210 Stanbio Laboratory | CHJ |
| May 26, 1978 | K780545 | SR-PLUS DIRECT CHOLESTEROL TEST Stanbio Laboratory | CGO |
| Mar 3, 1978 | K780110 | CSF TOTAL PROTEIN TEST SET #0340 Stanbio Laboratory | JGQ |
| Dec 22, 1977 | K772257 | ALKALINE PHOSPHATASE TEST SET Stanbio Laboratory | CIO |
| Nov 3, 1977 | K771856 | DIR. QUANT. COLOR. DETERM. SERUM CREAT. Stanbio Laboratory | CGX |
| Oct 7, 1977 | K771771 | QUAN. COLOR. DETER. OF SERUM ALBUMIN Stanbio Laboratory | DCF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2023 | Stanbio Laboratory, LP STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. Open, Classified |
JIN | None listed |
| Mar 16, 2022 | Stanbio Laboratory, LP Separation Technology Creamatocrit Plus, Catalog Number: 100-146 Terminated |
QEI | None listed |
| Jul 12, 2021 | Stanbio Laboratory, LP Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent. Terminated |
JIN | K910108 |
| Jul 12, 2021 | Stanbio Laboratory, LP Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Terminated |
JIN | K910108 |
| Jul 12, 2021 | Stanbio Laboratory, LP Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. Terminated |
JIN | K910108 |
| Jul 12, 2021 | Stanbio Laboratory, LP Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. Terminated |
JIN | K910108 |
| Jul 12, 2021 | Stanbio Laboratory, LP Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Terminated |
JIN | K910108 |
| Feb 13, 2018 | Stanbio Laboratory, LP RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30)
RF Latex (1156-001, Control# 172224 expiry 2019-12-31)
RF Latex (1155L-100B, Co Terminated |
DHR | K974370 |
| Feb 8, 2018 | Stanbio Laboratory, LP Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. Terminated |
GKR | K081719 |
| Nov 14, 2006 | Stanbio Laboratory, Inc Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Terminated |
LBR | K992002 |
| Nov 14, 2006 | Stanbio Laboratory, Inc Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme Terminated |
LBR | K992002 |
| Nov 14, 2006 | Stanbio Laboratory, Inc Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme Terminated |
LBR | K992002 |