Product code GIM
- Device name
- Tubes, Vacuum Sample, With Anticoagulant
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1675
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240455 | BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson and Company | 2024-10-31 |
| K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | Becton, Dickinson and Company | 2023-11-27 |
| K213670 | BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes | Becton, Dickinson and Company | 2023-08-25 |
| K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. | 2017-06-22 |
| K080552 | CYTO-CHEX BCT | Streck | 2008-07-31 |
| K012152 | DS30 HCY BLOOD COLLECTION TUBES | Drew Scientific , Ltd. | 2001-09-18 |
| K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | Becton Dickinson Vacutainer Systems | 1997-06-17 |
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE | Greiner America, Inc. | 1997-05-02 |
| K951886 | LOK-ON NEEDLE DISPOSAL SYSTEM | Becton Dickinson Vacutainer Systems | 1995-06-30 |
| K945458 | VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-02-06 |
| K944814 | CORVAC PLASTIC BLOOD COLLECTION TUBE | Sherwood Medical Co. | 1994-12-19 |
| K940058 | MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER | Sherwood Medical Co. | 1994-05-02 |
| K933939 | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT | Organon Teknika Corp. | 1994-02-07 |
| K933386 | VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-10-12 |
| K922858 | MULTIDRAW SYSTEM | Cambridge Multi-Draw, Inc. | 1992-11-16 |
| K922468 | ANGEL WING SETS -- MODIFIED | Mbo Laboratories, Inc. | 1992-07-10 |
| K921778 | DIRECTDRAW SUPERSERUM | International Technidyne Corp. | 1992-05-28 |
| K921636 | VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-29 |
| K920184 | ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. | Mbo Laboratories, Inc. | 1992-02-18 |
| K914901 | VACUTAINER KIT | Abbott Laboratories | 1992-01-08 |
| K915213 | CORVAC BLOOD COLLECTION TUBE | Sherwood Medical Co. | 1992-01-08 |
| K896373 | 1400 SERIES EVIDENCE COLLECTION KIT | Transidyne General Corp. | 1990-02-26 |
| K896514 | QS90 SMOOTH E ARTERIAL BLOOD SAMPLER | Radiometer America, Inc. | 1990-01-23 |
| K882501 | ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100 | Terumo Medical Corp. | 1988-07-18 |
| K861449 | VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) | Exel Intl. | 1986-09-16 |
| K803182 | SYRINGE FOR BLOOD SAMPLING | The University of Chicago | 1981-01-16 |
| K801015 | PREZAPAK L ARTERIAL BLOOD SAMPLING KIT | Kimble-Terumo, Inc. | 1980-05-14 |
| K791200 | PRE-DENT | Fichte, Graves, and Hunt | 1979-08-10 |
| K771874 | J-VAC VACUUM TUBE | Jelco Laboratories | 1977-12-02 |
| K771985 | FILTER SAMPLER BLOOD SERUM FILTER | Clasrock | 1977-11-02 |
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