GPS Platelet Separation Kit with Anticoagulant Acd-A
FDA 510(k) K030555 · Biomet, Inc.
510(k) numberK030555
Submission
- Device name
- GPS Platelet Separation Kit with Anticoagulant Acd-A
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- February 21, 2003
- Decision date
- April 11, 2003
- 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 GPS Platelet Separation Kit with Anticoagulant Acd-A cleared by the FDA?
GPS Platelet Separation Kit with Anticoagulant Acd-A (K030555) received a 510(k) decision of Substantially Equivalent on April 11, 2003, 49 days after the submission was received.
What is the product code of K030555?
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.