Vista Antigen Salmonella O Group C
FDA 510(k) K972388 · Lee Laboratories, Inc.
510(k) numberK972388
Submission
- Device name
- Vista Antigen Salmonella O Group C
- Applicant
- Lee Laboratories, Inc.
Grayson, GA, US - Received
- June 26, 1997
- Decision date
- August 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GNC – Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3550
- Specialty
- Microbiology
Other 510(k)s with product code GNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972395 | Vista Antigen Salmonella O Group DGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972392 | Vista Antigen Salmonella H aGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972391 | Vista Antigen Salmonella H BGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972390 | Vista Antigen Salmonella H CGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972389 | Vista Antigen Salmonella H DGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972387 | Vista Antigen Salmonella O Group aGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972386 | Vista Antigen Salmonella O Group BGNC · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K955228 | SAS Spicer-Edwards L ComplexGNC · Traditional | Sa Scientific, Inc. | 02/13/1996SE |
| K955227 | SAS Spicer-Edwards En Complex AntiserumGNC · Traditional | Sa Scientific, Inc. | 02/13/1996SE |
| K955226 | SAS Spicer-Edwards 4 AntiserumGNC · Traditional | Sa Scientific, Inc. | 02/13/1996SE |
More from Sa Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972396 | Vista Antigen Brucella MelitensisGSO · Traditional | 08/25/1997SE |
| K972395 | Vista Antigen Salmonella O Group DGNC · Traditional | 08/25/1997SE |
| K972394 | Vista Antigen Brucella AbortusGSO · Traditional | 08/25/1997SE |
| K972392 | Vista Antigen Salmonella H aGNC · Traditional | 08/25/1997SE |
| K972391 | Vista Antigen Salmonella H BGNC · Traditional | 08/25/1997SE |
| K972390 | Vista Antigen Salmonella H CGNC · Traditional | 08/25/1997SE |
| K972389 | Vista Antigen Salmonella H DGNC · Traditional | 08/25/1997SE |
| K972387 | Vista Antigen Salmonella O Group aGNC · Traditional | 08/25/1997SE |
| K972386 | Vista Antigen Salmonella O Group BGNC · Traditional | 08/25/1997SE |
Questions and answers
When was Vista Antigen Salmonella O Group C cleared by the FDA?
Vista Antigen Salmonella O Group C (K972388) received a 510(k) decision of Substantially Equivalent on August 25, 1997, 60 days after the submission was received.
What is the product code of K972388?
The FDA product code is GNC – Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3550.