Influenza Hi Antiserum
FDA 510(k) K780274 · Flow Laboratories, Inc.
510(k) numberK780274
Submission
- Device name
- Influenza Hi Antiserum
- 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
- GNS – Antisera, Hai, 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 GNS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K780697 | Goat Anti-Influenza Antisera AtexasGNS · Traditional | Northeast Biomedical Labs., Inc. | 05/03/1978SE |
| K780696 | Goat Antiinfluenza Antisera AussrGNS · Traditional | Northeast Biomedical Labs., Inc. | 05/03/1978SE |
| K780277 | Influenza Hi Preserum A/TexasGNS · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
| K780276 | Influenza Hi Antiserum A/TexasGNS · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
| K780273 | Influenza Hi PreserumGNS · Traditional | Flow Laboratories, Inc. | 02/28/1978SE |
| K780006 | Goat Anti-Influenza AntiseraGNS · Traditional | Northeast Biomedical Labs., Inc. | 01/20/1978SE |
| K780005 | Goat Anti-Influenza AntiseraGNS · Traditional | Northeast Biomedical Labs., Inc. | 01/20/1978SE |
| K780004 | Goat Anti-Influenza AntiseraGNS · Traditional | Northeast Biomedical Labs., Inc. | 01/20/1978SE |
More from Northeast Biomedical Labs., 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 Hi Antiserum cleared by the FDA?
Influenza Hi Antiserum (K780274) 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 K780274?
The FDA product code is GNS – Antisera, Hai, Influenza Virus A, B, C, a Class I (low risk) device regulated under 21 CFR 866.3330.