Liquichek HEMATOLOGY-16 Control LV, Model: 295LV
FDA 510(k) K091303 · Bio-Rad Laboratories
510(k) numberK091303
Submission
- Device name
- Liquichek HEMATOLOGY-16 Control LV, Model: 295LV
- Applicant
- Bio-Rad Laboratories
Irvine, CA, US - Received
- May 4, 2009
- Decision date
- August 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPK – Mixture, Hematology Quality Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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Questions and answers
When was Liquichek HEMATOLOGY-16 Control LV, Model: 295LV cleared by the FDA?
Liquichek HEMATOLOGY-16 Control LV, Model: 295LV (K091303) received a 510(k) decision of Substantially Equivalent on August 2, 2010, 455 days after the submission was received.
What is the product code of K091303?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.