Panels › Clinical Chemistry › Product code JIN · Class 1
Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation 862.1435
0510(k)s in 12 months (24 all time)
2recalls in 12 months (14 all time)
6recalls that name a 510(k)
Top companies in JIN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | DFI Co., Ltd. One Step K in vitro diagnostic test
REF: 81A4 Open, Classified |
JIN | None listed |
| Feb 4, 2026 | Changchun Wancheng Bio-Electron Co., Ltd. The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips;
URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein;
Vivoo Ketone Tes Open, Classified |
JIN | None listed |
| 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 |
| Oct 23, 2023 | Universal Meditech Inc. PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE Open, Classified |
JIN | None listed |
| Oct 23, 2023 | Universal Meditech Inc. HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips Open, Classified |
JIN | None listed |
| Mar 8, 2022 | MEDLINE INDUSTRIES, LP - Northfield Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL) Terminated |
JIN | 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 |
| Mar 15, 2021 | Medline Industries Inc Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test r Open, Classified |
JIN | None listed |
| Apr 20, 2020 | Cardinal Health Inc. B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma. Terminated |
JIN | None listed |
| Feb 28, 2020 | Abbott Diabetes Care, Inc. FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810 Terminated |
JIN | K060768 K070984 |
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