Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
The Thymolphthalein Monophosphate, Alkaline Phosphatase or Isoenzymes test system (product code CIO) is an in-vitro diagnostic device used in clinical chemistry to measure alkaline phosphatase activity or its isoenzymes in serum using thymolphthalein monophosphate as a chromogenic substrate, supporting the evaluation of liver and bone disease. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1050 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
- CIO
- Device Class
- FDA class 2
- Regulation Number
- 862.1050
- 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 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880177 | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | Apr 05, 1988 | Substantially Equivalent | Tech-Co, Inc. |
| K860351 | ALKALINE PHOSPHATASE REAGENT SET | Feb 11, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K855192 | ALKALINE PHOSPHATASE REAGENT SET | Jan 14, 1986 | Substantially Equivalent | Technostics Intl. |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Dec 10, 1984 | Substantially Equivalent | Sandare Chemical Co., Inc. |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | Nov 20, 1984 | Substantially Equivalent | Livonia Diagnostics, Inc. |
| K841064 | ALKALINE PHOSPHOTASE REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Jan 07, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
| K821200 | ALKALINE PHOSPHOTASE REAGENT SET | Jul 13, 1982 | Substantially Equivalent | Omega Medical Electronics |
| K781324 | ALP TEST | Aug 31, 1978 | Substantially Equivalent | Analytical & Research Chemicals, Inc. |
| K772257 | ALKALINE PHOSPHATASE TEST SET | Dec 22, 1977 | Substantially Equivalent | Stanbio Laboratory |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | May 03, 1977 | Substantially Equivalent | Icn Pharmaceuticals, Inc. |
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.