Calcium (Arsenazo III) for Manual/Auto Application
FDA 510(k) K894476 · Catachem, Inc.
510(k) numberK894476
Submission
- Device name
- Calcium (Arsenazo III) for Manual/Auto Application
- Applicant
- Catachem, Inc.
Port Chester, NY, US - Received
- July 18, 1989
- Decision date
- October 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | 01/19/2007SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | 02/22/1995SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | 09/08/1993SE |
| K903341 | MagnesiumJGJ · Traditional | 08/22/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | 07/31/1990SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | 07/27/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | 12/21/1989SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | 12/05/1989SE |
| K894715 | Creatine Kinase for Manual/Automated ApplicationsCGS · Traditional | 11/08/1989SE |
| K894389 | Creatinine for Manual or Automated ApplicationsGGX · Traditional | 10/12/1989SE |
Questions and answers
When was Calcium (Arsenazo III) for Manual/Auto Application cleared by the FDA?
Calcium (Arsenazo III) for Manual/Auto Application (K894476) received a 510(k) decision of Substantially Equivalent on October 12, 1989, 86 days after the submission was received.
What is the product code of K894476?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.