Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117
FDA 510(k) K061575 · Olympus America, Inc.
510(k) numberK061575
Submission
- Device name
- Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117
- Applicant
- Olympus America, Inc.
Irving, TX, US - Received
- June 7, 2006
- Decision date
- October 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY · Traditional | Horiba Abx SAS | 07/26/2019SE |
| 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 |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111788 | Endoeye HD IIHET · Traditional | 01/13/2012SE |
| K081615 | Olympus Cea - Carcinoembryonic AntigenDHX · Traditional | 03/18/2009SE |
| K073490 | Olympus Igg ReagentCFN · Traditional | 02/11/2008SE |
| K073489 | Olympus Iga ReagentCFN · Traditional | 02/11/2008SE |
| K073487 | Olympus Igm ReagentCFN · Traditional | 02/11/2008SE |
| K062862 | Olympus Uric Acid Reagent, Model OSR6X98KNK · Traditional | 04/06/2007SE |
| K063804 | Olympus Triglyceride Test SystemCDT · Traditional | 03/23/2007SE |
| K061499 | OsferionMQV · Traditional | 01/26/2007SE |
| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | 11/29/2006SE |
| K060201 | Olympus RF Latex Calibrator, and Olympus RF Latex Reagent with Model(S): ODC0028, and…DHR · Traditional | 06/06/2006SE |
Questions and answers
When was Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117 cleared by the FDA?
Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117 (K061575) received a 510(k) decision of Substantially Equivalent on October 5, 2006, 120 days after the submission was received.
What is the product code of K061575?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.