SAS Salmonella H L,V Antiserum
FDA 510(k) K955205 · Sa Scientific, Inc.
510(k) numberK955205
Submission
- Device name
- SAS Salmonella H L,V Antiserum
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- November 14, 1995
- Decision date
- February 2, 1996
- 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 |
| K972388 | Vista Antigen Salmonella O Group CGNC · 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 |
More from Sa Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132352 | SAS Flualert a & B, SAS Influenza a TestGNX · Special | 08/22/2013SE |
| K100227 | SAS Flualert A&B, SAS Influenza a TestPSZ · Special | 02/23/2010SE |
| K080380 | SAS Influenza a & B TestPSZ · Traditional | 07/23/2009SE |
| K061496 | SAS Legionella Test, SAS Legionella Dipstick TestMJH · Traditional | 06/28/2007SE |
| K041441 | SAS Influenza a TestPSZ · Traditional | 07/22/2004SE |
| K041439 | SAS Influenza B TestPSZ · Traditional | 07/22/2004SE |
| K030628 | SAS RSV Control KitJJX · Traditional | 03/17/2003SE |
| K022845 | SAS RSV TestGQG · Traditional | 01/29/2003SE |
| K022683 | SAS Blood/Serum/Urine/Urine HCGJHI · Traditional | 12/16/2002SE |
| K023270 | SAS StrepalertGTY · Traditional | 10/17/2002SE |
Questions and answers
When was SAS Salmonella H L,V Antiserum cleared by the FDA?
SAS Salmonella H L,V Antiserum (K955205) received a 510(k) decision of Substantially Equivalent on February 2, 1996, 80 days after the submission was received.
What is the product code of K955205?
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.