Pre-Dent
FDA 510(k) K791200 · Fichte, Graves, and Hunt
510(k) numberK791200
Submission
- Device name
- Pre-Dent
- Applicant
- Fichte, Graves, and Hunt
Mchenry, IL, US - Received
- June 28, 1979
- Decision date
- August 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIM – Tubes, Vacuum Sample, With Anticoagulant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code GIM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240455 | BD Vacutainer® Citrate Blood Collection TubesGIM · Traditional | Becton, Dickinson and Company | 10/31/2024SE |
| 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 |
| K012152 | DS30 Hcy Blood Collection TubesGIM · Traditional | Drew Scientific , Ltd. | 09/18/2001SE |
| 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 |
Questions and answers
When was Pre-Dent cleared by the FDA?
Pre-Dent (K791200) received a 510(k) decision of Substantially Equivalent on August 10, 1979, 43 days after the submission was received.
What is the product code of K791200?
The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.