Vigil Multichek Controls
FDA 510(k) K951170 · Beckman Instruments, Inc.
510(k) numberK951170
Submission
- Device name
- Vigil Multichek Controls
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- March 15, 1995
- Decision date
- April 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
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Questions and answers
When was Vigil Multichek Controls cleared by the FDA?
Vigil Multichek Controls (K951170) received a 510(k) decision of Substantially Equivalent on April 20, 1995, 36 days after the submission was received.
What is the product code of K951170?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.