FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
K Number: K042927
·
Decision Apr 15, 2005
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
7
Applicant Total
5
Review Days
175
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Basic Information
- Device Name
- VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES
- K Number
- K042927
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Greiner Bio-One Vacuette North America
- Date Received
- October 22, 2004
- Decision Date
- April 15, 2005
- Product Code
- PJE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PJE | Blood/Plasma Collection Device For Dna Testing | FDA class 2 | Clinical Chemistry |
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Other Clearances by Greiner Bio-One Vacuette North America
| K Number | Device Name | ||
|---|---|---|---|
| K080235 | SAFETY INFUSION SET | Apr 24, 2008 | Substantially Equivalent |
| K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER | Dec 29, 2003 | Substantially Equivalent |
| K023971 | VACUETTE TRACE ELEMENTS TUBES | Jan 27, 2003 | Substantially Equivalent |
| K011699 | VACUETTE EVACUATED BLOOD COLLECTION TUBES | Jun 28, 2001 | Substantially Equivalent |