GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A— 510(k) K030555
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K030555 for GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A, Substantially Equivalent on 2003-04-11. Applicant: Biomet, Inc.. Device class: 1.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code JQC
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JQC
view all- K183205 — PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
- K103340 — SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
- K081345 — AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
- K071934 — MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
- K070666 — GENESISCS COMPONENT CONCENTRATING SYSTEM
More clearances from Biomet, Inc.
view allAdverse events under product code JQC
product code JQC- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.