DS30 Hcy Blood Collection Tubes
FDA 510(k) K012152 · Drew Scientific , Ltd.
510(k) numberK012152
Submission
- Device name
- DS30 Hcy Blood Collection Tubes
- Applicant
- Drew Scientific , Ltd.
Barrow In Furness, GB - Received
- July 11, 2001
- Decision date
- September 18, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
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| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…GIM · Traditional | Becton, Dickinson and Company | 11/27/2023SE |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 08/25/2023SE |
| K162723 | TransFix/EDTA Vacuum Blood Collection TubesGIM · Traditional | Caltag Medsystems, Ltd. | 06/22/2017SE |
| K080552 | Cyto-Chex BCTGIM · Traditional | Streck | 07/31/2008SE |
| K971449 | Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)GIM · Traditional | Becton Dickinson Vacutainer Systems | 06/17/1997SE |
| K971221 | Greiner Vacuette Blood Collection TubeGIM · Traditional | Greiner America, Inc. | 05/02/1997SE |
| K951886 | Lok-On Needle Disposal SystemGIM · Traditional | Becton Dickinson Vacutainer Systems | 06/30/1995SE |
| K945458 | Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/06/1995SE |
| K944814 | Corvac Plastic Blood Collection TubeGIM · Traditional | Sherwood Medical Co. | 12/19/1994SE |
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|---|---|---|
| K071562 | D3 Hematology Analyzer, Model D3GKZ · Traditional | 12/11/2007SE |
| K070704 | Trilogy AnalyzerCGA · Traditional | 07/13/2007SE |
| K060510 | Drew Scientific Glycated Hemoglobin Five Level Linearity KitJJX · Traditional | 06/19/2006SE |
| K043378 | Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator KitJIT · Abbreviated | 12/29/2004SE |
| K982003 | DS30 Hcy Homocysteine Assay KitLPS · Traditional | 02/11/1999SE |
| K933287 | 745 GlycomatLCP · Traditional | 09/09/1993SE |
| K924496 | Glycomat Green HBA2 Estimation Reagent KitJPD · Traditional | 11/16/1992SE |
| K920198 | Glycomat Haemoglobin AnalyserLCP · Traditional | 07/21/1992SE |
Questions and answers
When was DS30 Hcy Blood Collection Tubes cleared by the FDA?
DS30 Hcy Blood Collection Tubes (K012152) received a 510(k) decision of Substantially Equivalent on September 18, 2001, 69 days after the submission was received.
What is the product code of K012152?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.