Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit
FDA 510(k) K071934 · Biomet Manufacturing Corp
510(k) numberK071934
Submission
- Device name
- Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- July 13, 2007
- Decision date
- October 11, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit cleared by the FDA?
Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit (K071934) received a 510(k) decision of Substantially Equivalent on October 11, 2007, 90 days after the submission was received.
What is the product code of K071934?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.