Sandare Fast 340 Phosphorus Procedure
FDA 510(k) K812670 · Sandare Chemical Co., Inc.
510(k) numberK812670
Submission
- Device name
- Sandare Fast 340 Phosphorus Procedure
- Applicant
- Sandare Chemical Co., Inc.
Mchenry, IL, US - Received
- September 21, 1981
- Decision date
- October 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CED – 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1520
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894288 | Phosphorus Test Item Number 65416CED · Traditional | Em Diagnostic Systems, Inc. | 08/31/1989SE |
| K840151 | Ektachem Clinical Chem. SlidesCED · Traditional | Eastman Kodak Company | 03/22/1984SE |
| K833710 | BTC Urine LH AssayCED · Traditional | Btc Diagnostics, Inc. | 01/30/1984SE |
| K820832 | Phosphorus IlCED · Traditional | American Monitor Corp. | 04/15/1982SE |
| K811864 | Sigma Procedure 265-UVCED · Traditional | Sigma Chemical Co. | 07/31/1981SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | Connecticut Diagnostics, Ltd. | 05/21/1981SE |
| K802420 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 10/31/1980SE |
| K790662 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 05/15/1979SE |
More from Union Carbide Corp.
| 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 |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | 12/10/1984SE |
| 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 |
Questions and answers
When was Sandare Fast 340 Phosphorus Procedure cleared by the FDA?
Sandare Fast 340 Phosphorus Procedure (K812670) received a 510(k) decision of Substantially Equivalent on October 2, 1981, 11 days after the submission was received.
What is the product code of K812670?
The FDA product code is CED – 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, a Class I (low risk) device regulated under 21 CFR 862.1520.