Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
FDA 510(k) K191396 · Horiba Abx SAS
510(k) numberK191396
Submission
- Device name
- Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
- Applicant
- Horiba Abx SAS
Montpellier Cedex 4, FR - Received
- May 24, 2019
- Decision date
- July 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJY – Azo Dye, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K244042 | Calcium2CJY · Traditional | Abbott Ireland | 02/10/2025SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | Randox Laboratories, Ltd. | 10/23/2018SE |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | Elitechgroup | 07/22/2015SE |
| K123171 | Abx Pentra Calcium AS CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…CJY · Abbreviated | Horiba Abx SAS | 07/03/2013SE |
| K120626 | Eon Calcium RegentCJY · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 08/22/2012SE |
| K083386 | Advia Chemistry CALCIUM_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…CJY · Traditional | Siemens Healthcare Diagnostics | 04/02/2009SE |
| K072356 | S-Test CaCJY · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | Thermofisher Scientific OY | 02/28/2008SE |
| K072443 | Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca AssayCJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/24/2007SE |
| K072440 | Vitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…CJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/20/2007SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232946 | Yumizen H2500GKZ · Traditional | 05/21/2024SE |
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | 05/10/2021SE |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | 06/26/2020SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | 06/25/2020SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | 03/06/2020SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | 10/03/2019SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | 08/30/2019SE |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CTGKZ · Traditional | 11/01/2017SE |
| K151133 | Pentra XLRGKZ · Traditional | 12/09/2015SE |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model)GKZ · Traditional | 12/20/2014SE |
Questions and answers
When was Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe cleared by the FDA?
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396) received a 510(k) decision of Substantially Equivalent on July 26, 2019, 63 days after the submission was received.
What is the product code of K191396?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.