VACUETTE EDTA K2 GEL TUBES
FDA 510(k) clearance K012043 · decided 2001-09-24
Clearance details
- K-number
- K012043
- Device name
- VACUETTE EDTA K2 GEL TUBES
- Applicant
- Greiner Vacuette North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-29
- Decision date
- 2001-09-24
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PJE
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Baldwin, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PAXgene® Blood DNA Tube (K231469) | Preanalytix GmbH | 2023-06-21 |
| PAXgene Blood DNA Tube (K142821) | Preanalytix GmbH | 2015-09-09 |
| VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (K042927) | Greiner Bio-One Vacuette North America | 2005-04-15 |
| S-MONOVETTE EDTA K2-GEL (K031359) | Sarstedt, Inc. | 2003-09-12 |
| VACUETTE EDTA K2 TUBES (K014104) | Greiner Vacuette North America, Inc. | 2002-02-01 |
| MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (K010328) | Izon Business Products, Inc. | 2001-04-09 |
| VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (K972075) | Becton Dickinson Vacutainer Systems | 1998-02-24 |
Recalls involving this device
No recalls on record reference this clearance.