Acid Phosphatase, Thymolphthale Inmonophosphate
The Acid Phosphatase, Thymolphthalein Monophosphate test system (product code CKE) is an in-vitro diagnostic device used in clinical chemistry to measure acid phosphatase activity in serum using thymolphthalein monophosphate as substrate under acidic pH conditions, supporting the evaluation of prostatic 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 862.1020 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CKE
- Device Class
- FDA class 2
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914167 | CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE | Mar 17, 1992 | Substantially Equivalent | Eastman Kodak Company |
| K915705 | ACID PHOSPHATASE REAGENT SET | Feb 27, 1992 | Substantially Equivalent | Tech Intl. Co. |
| K873726 | ACID PHOSPHATASE TEST | Jan 27, 1988 | Substantially Equivalent | King Diagnostics, Inc. |
| K864230 | DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM | Nov 28, 1986 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K860476 | ACID PHOSPHATASE REAGENT SET | Mar 05, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K843380 | ACID PHOSPHATASE ASSAY KIT | Sep 20, 1984 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
| K821526 | ACID PHOSPHATASE REAGENT SET | Jun 10, 1982 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
| K800693 | STANBIO PROSTATIC ACID PHOSPHATASE TEST | Apr 16, 1980 | Substantially Equivalent | Stanbio Laboratory |
| K790524 | DATA-ZYME ACIA PHOSPHATASE PROCEDURE | May 23, 1979 | Substantially Equivalent | Data Medical Associates, Inc. |
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.