Aalto Scientific Sweat Chloride Reference Material
FDA 510(k) K951435 · Aalto Scientific, Ltd.
510(k) numberK951435
Submission
- Device name
- Aalto Scientific Sweat Chloride Reference Material
- Applicant
- Aalto Scientific, Ltd.
Vista, CA, US - Received
- March 27, 1995
- Decision date
- May 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJR – Electrolyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990971 | Easylyte Quality Control Kit, Models 2814, 2815, 2816JJR · Traditional | Medica Corp. | 04/27/1999SE |
| K960592 | Electrolyte StandardsJJR · Traditional | Phoenix Diagnostics, Inc. | 05/13/1996SE |
| K955630 | RNA Medical Hemat ControlJJR · Traditional | Bionostics, Inc. | 03/01/1996SE |
| K943925 | Sweat Controls for Cystic Fibrosis TestingJJR · Traditional | Quantimetrix Corp. | 10/04/1994SE |
| K934641 | I-Stat Control Levels 1,2,3JJR · Traditional | I-Stat Corp. | 12/09/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | Verichem Laboratories, Inc. | 07/19/1991SE |
| K902266 | Electrolyte Controls (Assayed and Unassayed)JJR · Traditional | Phoenix Diagnostics, Inc. | 06/06/1990SE |
| K894576 | Ciba Corning Certain LyteJJR · Traditional | Ciba Corning Diagnostics Corp. | 10/30/1989SE |
| K895582 | Qclyte Protein-Based Ise ControlJJR · Traditional | Baxter Healthcare Corp | 10/04/1989SE |
| K881773 | Document(Tm) Direct Ise Linearity Test SetJJR · Traditional | Casco Standards | 06/10/1988SE |
More from Casco Standards
| 510(k) | Device | Decision |
|---|---|---|
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | 03/10/2017SE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | 08/10/2016SE |
| K143571 | Audit MicroControls Linearity LQ Cystatin-CJJX · Traditional | 01/23/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | 01/16/2015SE |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityJJX · Traditional | 11/21/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | 11/20/2014SE |
| K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity SetJJY · Traditional | 04/29/2013SE |
| K130764 | Audit Microcv Vitamin D Linearity SetJJX · Traditional | 04/26/2013SE |
| K130157 | Audit Microcv Beta-Hydroxybutyric Acid Linearity SetJJX · Traditional | 03/19/2013SE |
| K112742 | Audit Microlq Spinal Fluid ControlJJY · Traditional | 06/15/2012SE |
Questions and answers
When was Aalto Scientific Sweat Chloride Reference Material cleared by the FDA?
Aalto Scientific Sweat Chloride Reference Material (K951435) received a 510(k) decision of Substantially Equivalent on May 2, 1995, 36 days after the submission was received.
What is the product code of K951435?
The FDA product code is JJR – Electrolyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.