Liquichek Ck-Mb Control Levels 1,2, AND3
FDA 510(k) K925151 · Bio-Rad
510(k) numberK925151
Submission
- Device name
- Liquichek Ck-Mb Control Levels 1,2, AND3
- Applicant
- Bio-Rad
Anaheim, CA, US - Received
- October 13, 1992
- Decision date
- December 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJT – Enzyme 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 Ck-Mb Control Levels 1,2, AND3 cleared by the FDA?
Liquichek Ck-Mb Control Levels 1,2, AND3 (K925151) received a 510(k) decision of Substantially Equivalent on December 17, 1992, 65 days after the submission was received.
What is the product code of K925151?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.