CIO · Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1050 · Class 2
Overview
| Product Code | CIO |
|---|---|
| Device Name | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Classification Rationale
Class II.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880177 | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | Tech-Co, Inc. | Apr 5, 1988 | SESE |
| K860351 | ALKALINE PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | Feb 11, 1986 | SESE |
| K855192 | ALKALINE PHOSPHATASE REAGENT SET | Technostics Intl. | Jan 14, 1986 | SESE |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Sandare Chemical Co., Inc. | Dec 10, 1984 | SESE |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | Livonia Diagnostics, Inc. | Nov 20, 1984 | SESE |
| K841064 | ALKALINE PHOSPHOTASE REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Hoffmann-La Roche, Inc. | Jan 7, 1983 | SESE |
| K821200 | ALKALINE PHOSPHOTASE REAGENT SET | Omega Medical Electronics | Jul 13, 1982 | SESE |
| K781324 | ALP TEST | Analytical & Research Chemicals, Inc. | Aug 31, 1978 | SESE |
| K772257 | ALKALINE PHOSPHATASE TEST SET | Stanbio Laboratory | Dec 22, 1977 | SESE |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | Icn Pharmaceuticals, Inc. | May 3, 1977 | SESE |
Top Applicants
- Analytical & Research Chemicals, Inc. — 1 clearance
- Hoffmann-La Roche, Inc. — 1 clearance
- Icn Pharmaceuticals, Inc. — 1 clearance
- Livonia Diagnostics, Inc. — 1 clearance
- Medical Specialties, Inc. — 1 clearance
