Nod Chemistry Control
FDA 510(k) K060850 · Bioresource Technology, Inc.
510(k) numberK060850
Submission
- Device name
- Nod Chemistry Control
- Applicant
- Bioresource Technology, Inc.
Los Angeles, CA, US - Received
- March 28, 2006
- Decision date
- May 30, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Aalto Scientific, Ltd.
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|---|---|---|
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Questions and answers
When was Nod Chemistry Control cleared by the FDA?
Nod Chemistry Control (K060850) received a 510(k) decision of Substantially Equivalent on May 30, 2006, 63 days after the submission was received.
What is the product code of K060850?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.