GIM — Tubes, Vacuum Sample, With Anticoagulant Class II
FDA product code GIM covers "Tubes, Vacuum Sample, With Anticoagulant", a Class II medical device regulated under 21 CFR 862.1675. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GIM
- Device Class
- Class II
- Regulation Number
- 862.1675
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240455 | becton, dickinson and | BD Vacutainer® Citrate Blood Collection Tubes | October 31, 2024 |
| K230493 | becton, dickinson and | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blo | November 27, 2023 |
| K213670 | becton, dickinson and | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collecti | August 25, 2023 |
| K162723 | caltag medsystems | TransFix/EDTA Vacuum Blood Collection Tubes | June 22, 2017 |
| K080552 | streck | CYTO-CHEX BCT | July 31, 2008 |
| K012152 | drew scientific | DS30 HCY BLOOD COLLECTION TUBES | September 18, 2001 |
| K971449 | becton dickinson vacutainer systems | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | June 17, 1997 |
| K971221 | greiner america | GREINER VACUETTE BLOOD COLLECTION TUBE | May 2, 1997 |
| K951886 | becton dickinson vacutainer systems | LOK-ON NEEDLE DISPOSAL SYSTEM | June 30, 1995 |
| K945458 | bd becton dickinson vacutainer systems preanalytic | VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM | February 6, 1995 |
| K944814 | sherwood medical | CORVAC PLASTIC BLOOD COLLECTION TUBE | December 19, 1994 |
| K940058 | sherwood medical | MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER | May 2, 1994 |
| K933939 | organon teknika | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT | February 7, 1994 |
| K933386 | bd becton dickinson vacutainer systems preanalytic | VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM | October 12, 1993 |
| K922858 | cambridge multi-draw | MULTIDRAW SYSTEM | November 16, 1992 |
| K922468 | mbo laboratories | ANGEL WING SETS -- MODIFIED | July 10, 1992 |
| K921778 | international technidyne | DIRECTDRAW SUPERSERUM | May 28, 1992 |
| K921636 | bd becton dickinson vacutainer systems preanalytic | VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET | April 29, 1992 |
| K920184 | mbo laboratories | ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. | February 18, 1992 |
| K915213 | sherwood medical | CORVAC BLOOD COLLECTION TUBE | January 8, 1992 |