Rightest Control Solution
FDA 510(k) K133003 · Bionime Corporation
510(k) numberK133003
Submission
- Device name
- Rightest Control Solution
- Applicant
- Bionime Corporation
Great Neck, NY, US - Received
- September 25, 2013
- Decision date
- October 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | 11/04/2024SE |
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| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest…NBW · Traditional | 07/06/2017SE |
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Questions and answers
When was Rightest Control Solution cleared by the FDA?
Rightest Control Solution (K133003) received a 510(k) decision of Substantially Equivalent on October 24, 2013, 29 days after the submission was received.
What is the product code of K133003?
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.