Liquichek BNP Control
FDA 510(k) K043584 · Bio-Rad Laboratories, Inc.
510(k) numberK043584
Submission
- Device name
- Liquichek BNP Control
- Applicant
- Bio-Rad Laboratories, Inc.
Irvine, CA, US - Received
- December 28, 2004
- Decision date
- February 8, 2005
- 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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Questions and answers
When was Liquichek BNP Control cleared by the FDA?
Liquichek BNP Control (K043584) received a 510(k) decision of Substantially Equivalent on February 8, 2005, 42 days after the submission was received.
What is the product code of K043584?
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.