Liqui-Sera Combo Ligand/Tdm Controls
FDA 510(k) K863849 · Biodiagnostic Intl
510(k) numberK863849
Submission
- Device name
- Liqui-Sera Combo Ligand/Tdm Controls
- Applicant
- Biodiagnostic Intl
La Habra, CA, US - Received
- September 30, 1986
- Decision date
- November 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJY
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|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K031296 | Liqui-Heme Glyco A1C AssayLCP · Traditional | 10/15/2004SE |
| K881430 | Liqui-Sera Serum Alcohol ControlsJJX · Traditional | 07/08/1988SE |
| K874459 | Liqui-Sera Spinal Fluid ControlJJY · Traditional | 12/29/1987SE |
| K853906 | Liqui-Sera Chemistry Controls (Comprehensive)JJY · Traditional | 10/04/1985SE |
| K853887 | Liqui-Sera Chem. Multiple CalibratorsJIT · Traditional | 09/30/1985SE |
| K842668 | Liqui-Heme Hemoglobin CalibratorsKRZ · Traditional | 03/05/1985SE |
| K840618 | Liqui-Ura Chemistry Urine ControlsJJW · Traditional | 04/04/1984SE |
| K834398 | Liqui-Sera TDM CalibratorsDKB · Traditional | 02/03/1984SE |
| K834259 | Liqui-Ura Toxic Urine ControlDIF · Traditional | 01/30/1984SE |
| K831278 | Liqui-Sera Anticonvulsants ControlsDIF · Traditional | 05/27/1983SE |
Questions and answers
When was Liqui-Sera Combo Ligand/Tdm Controls cleared by the FDA?
Liqui-Sera Combo Ligand/Tdm Controls (K863849) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 55 days after the submission was received.
What is the product code of K863849?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.