SAS Salmonella H B Antigen
FDA 510(k) K952136 · Sa Scientific, Inc.
510(k) numberK952136
Submission
- Device name
- SAS Salmonella H B Antigen
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- May 8, 1995
- Decision date
- July 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GSO – Antigens (Febrile), Agglutination, Brucella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3085
- Specialty
- Microbiology
Other 510(k)s with product code GSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972396 | Vista Antigen Brucella MelitensisGSO · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K972394 | Vista Antigen Brucella AbortusGSO · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K952139 | SAS Brucella Suis AntigenGSO · Traditional | Sa Scientific, Inc. | 07/18/1995SE |
| K952147 | SAS Brucella Abortus AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952140 | SAS Brucella Meltiensis AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952137 | SAS Salmonella H a AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952135 | SAS Salmonella H D AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952131 | SAS Febrile Antigen SetGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K885112 | Brucella Ifa*GSO · Traditional | Investigacion Farmaceutica S.A. DE C.V. | 08/15/1989SE |
| K822663 | Febrile Antigen KitGSO · Traditional | Oxoid U.S.A., Inc. | 09/21/1982SE |
More from Oxoid U.S.A., 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 B Antigen cleared by the FDA?
SAS Salmonella H B Antigen (K952136) received a 510(k) decision of Substantially Equivalent on July 17, 1995, 70 days after the submission was received.
What is the product code of K952136?
The FDA product code is GSO – Antigens (Febrile), Agglutination, Brucella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3085.