Tri-Level Bilirubin Controls
FDA 510(k) K833898 · Sandare Chemical Co., Inc.
510(k) numberK833898
Submission
- Device name
- Tri-Level Bilirubin Controls
- Applicant
- Sandare Chemical Co., Inc.
Mchenry, IL, US - Received
- November 14, 1983
- Decision date
- January 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Siemens Healthcare Diagnostics, 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 |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | 12/10/1984SE |
| K842516 | Sandare Acid Phosphatase ProcedureCJR · Traditional | 08/17/1984SE |
| 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 Tri-Level Bilirubin Controls cleared by the FDA?
Tri-Level Bilirubin Controls (K833898) received a 510(k) decision of Substantially Equivalent on January 13, 1984, 60 days after the submission was received.
What is the product code of K833898?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.