Single Reagent Calcium for Demand Analyzer
FDA 510(k) K880949 · Advanced Biomedical Methods, Inc.
510(k) numberK880949
Submission
- Device name
- Single Reagent Calcium for Demand Analyzer
- Applicant
- Advanced Biomedical Methods, Inc.
Niles, IL, US - Received
- March 7, 1988
- Decision date
- April 5, 1988
- 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 |
| 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 |
|---|---|---|
| K945353 | Clarit(Tm)JKA · Traditional | 12/09/1994SE |
| K864866 | Resubmission of the Kleerzit ReagentJKA · Traditional | 03/16/1987SE |
| K852784 | Alkaline PhosphataseCJE · Traditional | 07/22/1985SE |
| K852783 | Sgot/Alt ReagentCIT · Traditional | 07/22/1985SE |
| K852027 | GGTP Reagent/Serum Iron/Salicylate Demand AnalyzerDKJ · Traditional | 05/29/1985SE |
| K850381 | Magnesium Reagent for Demand AnalyzerJGJ · Traditional | 03/01/1985SE |
| K850380 | Inorganic Phosphorous for Demand AnalyzerCEO · Traditional | 03/01/1985SE |
| K850379 | Direct Bilirubin for Demand AnalyzerCIG · Traditional | 03/01/1985SE |
| K850378 | LDH Reagent for Demand AnalyzerCFJ · Traditional | 03/01/1985SE |
| K844332 | Creatinine Reagent for Demand AnalyzerCGX · Traditional | 01/03/1985SE |
Questions and answers
When was Single Reagent Calcium for Demand Analyzer cleared by the FDA?
Single Reagent Calcium for Demand Analyzer (K880949) received a 510(k) decision of Substantially Equivalent on April 5, 1988, 29 days after the submission was received.
What is the product code of K880949?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.