Modification to Raichem Calcium Reagent
FDA 510(k) K022049 · Hemagen Diagnostics, Inc.
510(k) numberK022049
Submission
- Device name
- Modification to Raichem Calcium Reagent
- Applicant
- Hemagen Diagnostics, Inc.
Columbia, MD, US - Received
- June 24, 2002
- Decision date
- July 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K041052 | Raichem Glucose UV (Liquid)CFR · Traditional | 06/30/2004SE |
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | 06/30/2004SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | 06/25/2004SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | 06/16/2003SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | 12/24/2002SE |
| K022772 | Raichem Ldl-Cholesterol Direct ReagentMRR · Traditional | 09/17/2002SE |
| K022767 | Raichem Lipid CalibratorJIX · Special | 09/03/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | 10/15/2001SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | 10/15/2001SE |
Questions and answers
When was Modification to Raichem Calcium Reagent cleared by the FDA?
Modification to Raichem Calcium Reagent (K022049) received a 510(k) decision of Substantially Equivalent on July 19, 2002, 25 days after the submission was received.
What is the product code of K022049?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.