Directigen Flu a
FDA 510(k) K902609 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK902609
Submission
- Device name
- Directigen Flu a
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- June 12, 1990
- Decision date
- September 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNT – Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3330
- Specialty
- Microbiology
Other 510(k)s with product code GNT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950838 | Virazyme Culture Confirmation Screen for Influenza and Parainfluenza VirusesGNT · Traditional | Zymetx, Inc. | 06/17/1996SE |
| K913828 | Qtest Influenza aGNT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/23/1991SE |
| K780275 | Influenza Ha Antigen A/UssrGNT · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
| K780272 | Influenza Ha AntigenGNT · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Directigen Flu a cleared by the FDA?
Directigen Flu a (K902609) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 90 days after the submission was received.
What is the product code of K902609?
The FDA product code is GNT – Antigens, Ha (Including Ha Control), Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.