Methylthymol Blue, Calcium
The Methylthymol Blue, Calcium test system (product code CIA) is an in-vitro diagnostic device used in clinical chemistry to measure calcium concentrations in serum or urine using a colorimetric method based on methylthymol blue dye chelation, a common automated laboratory technique. 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
- CIA
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | Aug 19, 1987 | Substantially Equivalent | Trace Scientific , Ltd. |
| K863059 | CALCIOMETER | Sep 26, 1986 | Substantially Equivalent | J. D. Assoc. |
| K822898 | DSL 1600 | Dec 09, 1982 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K792396 | ELVI CALCIUM | Dec 06, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
| K771468 | MULTISTAT III CALCIUM TEST | Sep 12, 1977 | Substantially Equivalent | Instrumentation Laboratory CO |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.