Multi-Analyte Lin-Trol
FDA 510(k) K863751 · Sigma Diagnostics, Inc.
510(k) numberK863751
Submission
- Device name
- Multi-Analyte Lin-Trol
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- September 25, 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
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| 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 |
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| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
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| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Multi-Analyte Lin-Trol cleared by the FDA?
Multi-Analyte Lin-Trol (K863751) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 60 days after the submission was received.
What is the product code of K863751?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.