Titrimetric With Edta And Indicator, Calcium
The Titrimetric with EDTA and Indicator, Calcium test system (product code CHW) is an in-vitro diagnostic device used in clinical chemistry to measure calcium concentrations in serum or urine using a titrimetric method with ethylenediaminetetraacetic acid (EDTA) as a chelating agent and a chromogenic indicator. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1145 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CHW
- Device Class
- FDA class 2
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | Sep 09, 2020 | Substantially Equivalent | Biosystems S.A. |
| K113521 | CALCIUM GEN. 2 | May 08, 2012 | Substantially Equivalent | Roche Diagnostics |
| K781454 | LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA | Sep 20, 1978 | Substantially Equivalent | Union Carbide Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.