CLP Total Iron and Uibc/Tibc Linearity Control Set
FDA 510(k) K942284 · Creative Laboratory Products, Inc.
510(k) numberK942284
Submission
- Device name
- CLP Total Iron and Uibc/Tibc Linearity Control Set
- Applicant
- Creative Laboratory Products, Inc.
Indianapolis, IN, US - Received
- May 11, 1994
- Decision date
- August 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K950589 | CLP High Level High Density Lipo Protein Cholesterol Control-HlJJX · Traditional | 03/20/1995SE |
| K922995 | Lipid ControlsJJX · Traditional | 08/12/1992SE |
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| K913371 | Total Iron and Unsat Iron Bind Capac/Iron Bind CalJIT · Traditional | 11/08/1991SE |
| K913585 | Lipase Linearity ControlJJX · Traditional | 10/21/1991SE |
| K913224 | Lipid Linearity ControlsJJY · Traditional | 09/25/1991SE |
| K913496 | Cholinesterase Linearity ControlJJX · Traditional | 09/11/1991SE |
| K912823 | High Density Lipoprotein CholesterolLBR · Traditional | 08/16/1991SE |
| K912725 | Total Iron & Unsat Iron Bind Cap/Iron Bind ControlJJY · Traditional | 07/30/1991SE |
| K904989 | CLP Low Level HDL Cholesterol-Lipid Control-IiJJY · Traditional | 01/23/1991SE |
Questions and answers
When was CLP Total Iron and Uibc/Tibc Linearity Control Set cleared by the FDA?
CLP Total Iron and Uibc/Tibc Linearity Control Set (K942284) received a 510(k) decision of Substantially Equivalent on August 26, 1994, 107 days after the submission was received.
What is the product code of K942284?
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.