Rterial Blood Sampling Kit
FDA 510(k) K771489 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK771489
Submission
- Device name
- Rterial Blood Sampling Kit
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- August 5, 1977
- Decision date
- August 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJE – Tray, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code GJE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962596 | Customed Blood Extraction KitGJE · Traditional | Customed, Inc. | 09/27/1996SE |
| K925468 | JJ Skinner Carekits(Tm) Blood Collection KitGJE · Traditional | J.J. Skinner, Inc. | 04/11/1994SEKD |
| K780303 | Auto Iso-Filter Collection Tube CapGJE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/30/1978SE |
| K771370 | Icrotaineo Brand TubeGJE · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1977SE |
| K761177 | Sodium CitrateGJE · Traditional | Bio/Data Corp. | 01/10/1977SE |
| K760086 | Tray, Blood Sampling (Pulsator II)GJE · Traditional | Concord Laboratories, Inc. | 07/16/1976SE |
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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
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| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
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Questions and answers
When was Rterial Blood Sampling Kit cleared by the FDA?
Rterial Blood Sampling Kit (K771489) received a 510(k) decision of Substantially Equivalent on August 22, 1977, 17 days after the submission was received.
What is the product code of K771489?
The FDA product code is GJE – Tray, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.