Alkaline Phosphatase Reagent Set
FDA 510(k) K844237 · Livonia Diagnostics, Inc.
510(k) numberK844237
Submission
- Device name
- Alkaline Phosphatase Reagent Set
- Applicant
- Livonia Diagnostics, Inc.
Livonia, MI, US - Received
- November 1, 1984
- Decision date
- November 20, 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 |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | Sandare Chemical Co., Inc. | 12/10/1984SE |
| 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 |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| K844322 | Sgot Reagent SetCIQ · Traditional | 11/27/1984SE |
| K844283 | SGPT Reagent SetCKD · Traditional | 11/27/1984SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | 11/13/1984SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | 11/09/1984SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | 11/02/1984SE |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | 10/30/1984SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | 10/30/1984SE |
| K843895 | Total Calcium Reagent SetCIC · Traditional | 10/30/1984SE |
| K843893 | Magnesium Reagent SetJGJ · Traditional | 10/30/1984SE |
Questions and answers
When was Alkaline Phosphatase Reagent Set cleared by the FDA?
Alkaline Phosphatase Reagent Set (K844237) received a 510(k) decision of Substantially Equivalent on November 20, 1984, 19 days after the submission was received.
What is the product code of K844237?
The FDA product code is CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.