Hi Chem Calcium Reagent #88808
FDA 510(k) K890584 · Hichem Diagnostics
510(k) numberK890584
Submission
- Device name
- Hi Chem Calcium Reagent #88808
- Applicant
- Hichem Diagnostics
Brea, CA, US - Received
- February 6, 1989
- Decision date
- April 10, 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
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|---|---|---|---|
| K244042 | Calcium2CJY · Traditional | Abbott Ireland | 02/10/2025SE |
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| 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 |
|---|---|---|
| K981794 | Hichem Calcium Reagent KitCJY · Traditional | 07/29/1998SE |
| K963383 | Hichem Alp/Amp Reagent KitCKF · Traditional | 09/23/1996SE |
| K953863 | Hichem Ise Standards Kit 70011JIX · Traditional | 09/06/1995SE |
| K953862 | Hichem Isekci Solution Kit 70010CGZ · Traditional | 09/06/1995SE |
| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | 09/06/1995SE |
| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | 09/06/1995SE |
| K951751 | Hichem Ast Reagent KitCIT · Traditional | 08/02/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | 05/02/1995SE |
| K946022 | Hichem Ldh/L Reagent KitCFJ · Traditional | 02/23/1995SE |
| K941433 | Hi Chem Aqueous Glucose Control, Low, Med, HighJJX · Traditional | 08/02/1994SE |
Questions and answers
When was Hi Chem Calcium Reagent #88808 cleared by the FDA?
Hi Chem Calcium Reagent #88808 (K890584) received a 510(k) decision of Substantially Equivalent on April 10, 1989, 63 days after the submission was received.
What is the product code of K890584?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.