This page includes the latest FDA filings for Arkray Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Arkray Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
Device Company | Device | Date |
|---|---|---|
| ARKRAY USA, INC. | SPOTCHEM™ II Basic Panel 2 | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Basic Panel 1 | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Lipid Panel | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II HDL-Cholesterol | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II LDH | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Magnesium | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Inorganic Phosphorous | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Fructosamine | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Creatinine | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II ALP | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II GGT | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Amylase | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II CPK | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II ALT / GPT | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II AST / GOT | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Albumin | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Total Protein | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Calcium | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Total Bilirubin | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II BUN | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Triglycerides | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Total Cholesterol | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Uric Acid | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ II Glucose | 2024-05-31 |
| ARKRAY USA, INC. | SPOTCHEM™ EZ Analyzer | 2024-05-31 |
| ARKRAY USA, INC. | TechLITE PLUS PEN NEEDLES | 2024-03-19 |
| ARKRAY USA, INC. | TechLITE® Lancets, 26g | 2023-10-05 |
| ARKRAY USA, INC. | TechLITE® Lancets, 28g | 2023-09-27 |
| ARKRAY USA, INC. | TechLITE PEN NEEDLES | 2023-09-08 |
| ARKRAY USA, INC. | TechLITE PEN NEEDLES | 2023-09-08 |
| ARKRAY USA, INC. | TechLITE PEN NEEDLES | 2023-09-08 |
| ARKRAY USA, INC. | TechLITE PEN NEEDLES | 2023-09-08 |
| ARKRAY USA, INC. | TechLITE PEN NEEDLES | 2023-09-08 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 1mL 31G x 15/64" (6mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 0.5mL 31G x 15/64" (6mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 0.3mL 31G x 15/64" (6mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 1mL 31G x 5/16" (8mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 0.5mL 31G x 5/16" (8mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 0.3mL 31G x 5/16" (8mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 1mL 30G x 1/2" (12mm) | 2023-07-28 |
| ARKRAY USA, INC. | TechLITE Insulin Syringes 0.5mL 30G x 1/2" (12mm) | 2023-07-28 |
| ARKRAY USA, INC. | Assure® Lance Plus Safety Lancets | 2023-03-10 |
| ARKRAY USA, INC. | Assure® Lance Plus Safety Lancets | 2023-03-10 |
| ARKRAY USA, INC. | Assure® Lance Safety Lancets N/A | 2023-03-10 |
| ARKRAY USA, INC. | Assure® Lance Safety Lancets | 2023-03-10 |
| ARKRAY USA, INC. | Assure® Lance Safety Lancets | 2023-03-10 |
| ARKRAY USA, INC. | ARKRAY Multi-let 2 Lancing Device | 2023-03-08 |
| ARKRAY USA, INC. | AUTION™ Sticks 9EB Test Strips | 2022-09-16 |
| ARKRAY USA, INC. | Aution™ Hybrid AU-4050 Chemical Analyzer | 2022-09-16 |
| ARKRAY USA, INC. | AUTION™ MAX AX-4030 Analyzer | 2022-09-16 |
| ARKRAY USA, INC. | GLUCOCARD® Vital™ Blood Glucose Meter | 2022-06-27 |
| ARKRAY USA, INC. | Assure® Prism Multi Blood Glucose Meter | 2022-06-27 |
| ARKRAY USA, INC. | Assure® Platinum Blood Glucose Meter | 2022-06-27 |
| ARKRAY USA, INC. | Assure® ID DUO PRO Safety Pen Needles 31gx5mm Sample 10's | 2021-10-11 |
| ARKRAY USA, INC. | Assure® ID DUO PRO Safety Pen Needles 31gx5mm 100's | 2021-10-11 |
| ARKRAY USA, INC. | Assure® ID PRO Safety Pen Needles 30gx5mm 100's | 2021-10-11 |
| ARKRAY USA, INC. | Assure® SD Sharps Container | 2021-03-08 |
| ARKRAY USA, INC. | Assure® SD Sharps Container | 2021-03-08 |
| ARKRAY USA, INC. | Assure® SD Sharps Container | 2021-03-08 |
| ARKRAY USA, INC. | Assure® SD Sharps Container | 2021-03-08 |
| ARKRAY USA, INC. | Assure® SD Sharps Container | 2021-03-08 |
| ARKRAY USA, INC. | Assure® Lance Safety Lancets | 2020-08-06 |
| ARKRAY USA, INC. | Assure® Lance Safety Lancets | 2020-08-06 |
| ARKRAY USA, INC. | Assure® Lance Safety Lancets | 2020-08-06 |
| ARKRAY USA, INC. | Assure® Dose High (Level 2) Control Solution | 2020-08-06 |
| ARKRAY USA, INC. | Assure® Slide Pill Swallowing Aid zero | 2020-07-23 |
| ARKRAY USA, INC. | Assure® Slide Pill Swallowing Aid forte | 2020-07-23 |
| ARKRAY USA, INC. | Assure® Lance | 2020-04-06 |
| ARKRAY USA, INC. | ARK Care® VITA Patient Mobile Application | 2020-03-20 |
| ARKRAY USA, INC. | ReliOn™ Life Patient Mobile Application | 2020-03-20 |
| ARKRAY USA, INC. | ARK Care® Advance Diabetes Management System | 2020-03-20 |
| ARKRAY USA, INC. | Assure® Dose High (Level 2) Control Solution | 2020-03-09 |
| ARKRAY USA, INC. | Assure® Dose Normal (Level 1) Control Solution | 2020-03-09 |
| ARKRAY USA, INC. | AUTION Check Plus Controls | 2020-03-05 |
| ARKRAY USA, INC. | Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100's | 2020-01-29 |
| ARKRAY USA, INC. | Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's | 2020-01-29 |
| ARKRAY USA, INC. | Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's | 2020-01-29 |
| ARKRAY USA, INC. | Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10's | 2020-01-29 |
| ARKRAY USA, INC. | Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's | 2020-01-22 |
| ARKRAY USA, INC. | Assure® ID Safety Pen Needles, 30G x 5mm Sample 10's | 2020-01-22 |
| ARKRAY USA, INC. | GLUCOCARD® W Blood Glucose Test Strips | 2019-04-09 |
| ARKRAY USA, INC. | GLUCOCARD® W Blood Glucose Monitoring System | 2019-04-09 |
| ARKRAY USA, INC. | Assure® Control Level 3 Control Solution (High) | 2019-04-09 |
| ARKRAY USA, INC. | Assure® Control Level 2 Control Solution (Normal) | 2019-04-09 |
| ARKRAY USA, INC. | Assure® Control Level 1 Control Solution (Low) | 2019-04-09 |
| ARKRAY USA, INC. | Aution™ AU Control Solution | 2018-10-26 |
| ARKRAY USA, INC. | GLUCOCARD® Vital™ Blood Glucose Monitoring System | 2018-07-06 |
| ARKRAY USA, INC. | GLUCOCARD® Vital™ Blood Glucose Monitoring System | 2018-07-06 |
| ARKRAY USA, INC. | GLUCOCARD® Shine XL Blood Glucose Monitoring Syste | 2018-07-06 |
| ARKRAY USA, INC. | GLUCOCARD® Shine Blood Glucose Monitoring System | 2018-07-06 |
| ARKRAY USA, INC. | HEMOLYSIS WASHING SOLUTION 80H | 2018-07-06 |
| ARKRAY USA, INC. | ELUENT 80CV | 2018-07-06 |
| ARKRAY USA, INC. | ELUENT 80B | 2018-07-06 |
| ARKRAY USA, INC. | ELUENT 80A | 2018-07-06 |
| ARKRAY USA, INC. | AUTION™ Diluent SED | 2018-07-06 |
| ARKRAY USA, INC. | AUTION™ Uriflet 9HA Test Strips | 2018-07-06 |
| ARKRAY USA, INC. | Calibrator 80 | 2018-07-06 |
| ARKRAY USA, INC. | DILUENT 80 | 2018-07-06 |
| ARKRAY USA, INC. | ADAMS™ A1c HA-8180V (UL) Analyzer | 2018-07-06 |
| ARKRAY USA, INC. | S.G. Calibrator H | 2018-07-06 |
| NCAGE Code | 367L8 | ARKRAY USA, INC. |
| CAGE Code | 367L8 | ARKRAY USA, INC. |
| S.A.M. Registration | 367L8 [867773280] | ARKRAY USA, INC. |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2018120476743 | Anvers,Belgium -> New York/Newark Area, Newark, New Jersey | SLIDE MEDICATION LUBRICANTS HS CODE: 30067000 FREIGHT PREPAID CARGO IS STOWED IN A REFRIGERATED CONTAINER S AT THE SHIPPER'S REQUESTED CARRYING TEMPERATU OF 15 DEGREES CELSIUS | 188 PCS |