Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529
FDA 510(k) K984477 · Bio-Rad
510(k) numberK984477
Submission
- Device name
- Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- December 16, 1998
- Decision date
- January 29, 1999
- 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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Questions and answers
When was Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 cleared by the FDA?
Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 (K984477) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 44 days after the submission was received.
What is the product code of K984477?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.