Sandare Alkaline Phosphatase Procedure
FDA 510(k) K844498 · Sandare Chemical Co., Inc.
510(k) numberK844498
Submission
- Device name
- Sandare Alkaline Phosphatase Procedure
- Applicant
- Sandare Chemical Co., Inc.
Desoto, TX, US - Received
- November 20, 1984
- Decision date
- December 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880177 | Alkaline Phosphatase, Thymolphthalein MonophosphatCIO · Traditional | Tech-Co, Inc. | 04/05/1988SE |
| K860351 | Alkaline Phosphatase Reagent SetCIO · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K855192 | Alkaline Phosphatase Reagent SetCIO · Traditional | Technostics Intl. | 01/14/1986SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | Livonia Diagnostics, Inc. | 11/20/1984SE |
| K841064 | Alkaline Phosphotase Reagent SetCIO · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K823578 | Cobas Standards for Calcium-In-OrganicCIO · Traditional | Hoffmann-La Roche, Inc. | 01/07/1983SE |
| K821200 | Alkaline Phosphotase Reagent SetCIO · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K781324 | Alp TestCIO · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| K772257 | Alkaline Phosphatase Test SetCIO · Traditional | Stanbio Laboratory | 12/22/1977SE |
| K770453 | Phosphatase Procedure, Tekpoint AlkalineCIO · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |
More from Icn Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872852 | Eagle Diagnostics Glycohemoglobin Unitized TestLCP · Traditional | 09/29/1987SE |
| K862556 | Sandare Glycohemoglobin ProcedureLCP · Traditional | 08/08/1986SE |
| K860684 | Sandare BCG Albumin ProcedureCIX · Traditional | 03/17/1986SE |
| K851395 | Sandare Iron-Binding Capacity ProcedureJMO · Traditional | 05/07/1985SE |
| K851394 | Sandare Iron ProcedureJIY · Traditional | 04/30/1985SE |
| K842516 | Sandare Acid Phosphatase ProcedureCJR · Traditional | 08/17/1984SE |
| K833898 | Tri-Level Bilirubin ControlsJJX · Traditional | 01/13/1984SE |
| K832942 | Total & Direct Bilirubin ProceduresCIG · Traditional | 11/07/1983SE |
| K832632 | Albumin Procedure BCPCJW · Traditional | 09/12/1983SE |
| K832183 | Sandare Calcium ProcedureCIC · Traditional | 08/24/1983SE |
Questions and answers
When was Sandare Alkaline Phosphatase Procedure cleared by the FDA?
Sandare Alkaline Phosphatase Procedure (K844498) received a 510(k) decision of Substantially Equivalent on December 10, 1984, 20 days after the submission was received.
What is the product code of K844498?
The FDA product code is CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.