Influenza Ha Antigen
FDA 510(k) K780272 · Flow Laboratories, Inc.
510(k) numberK780272
Submission
- Device name
- Influenza Ha Antigen
- Applicant
- Flow Laboratories, Inc.
Mchenry, IL, US - Received
- February 17, 1978
- Decision date
- February 28, 1978
- 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 |
| K902609 | Directigen Flu aGNT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/10/1990SE |
| K780275 | Influenza Ha Antigen A/UssrGNT · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
More from Flow Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844567 | Titertek Twinreader 78-630-00JJQ · Traditional | 03/21/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Influenza Ha Antigen cleared by the FDA?
Influenza Ha Antigen (K780272) received a 510(k) decision of Substantially Equivalent on February 28, 1978, 11 days after the submission was received.
What is the product code of K780272?
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.