SAS Salmonella O Group U Factor 43 Antiserum
FDA 510(k) K960463 · Sa Scientific, Inc.
510(k) numberK960463
Submission
- Device name
- SAS Salmonella O Group U Factor 43 Antiserum
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- January 30, 1996
- Decision date
- March 6, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GRM – Antisera, All Groups, Salmonella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3550
- Specialty
- Microbiology
Other 510(k)s with product code GRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961967 | SAS Salmonella O Poly B AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961966 | SAS Salmonella O Group X Factor 47 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961964 | SAS Salmonella O Group H Factors 14,24,25 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961963 | SAS Salmonella O Group W Factor 45 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961962 | SAS Salmonella O Group V Factor 44 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961961 | SAS Salmonella H F,G,T AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961960 | SAS Salmonella H Z4, Z24 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961958 | SAS Salmonella H Z4 Complex AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961957 | SAS Salmonella H Z4, Z32 AntiserumGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
| K961956 | SAS Salmonella H G,M,Q AntisermuGRM · Traditional | Sa Scientific, Inc. | 06/18/1996SE |
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 O Group U Factor 43 Antiserum cleared by the FDA?
SAS Salmonella O Group U Factor 43 Antiserum (K960463) received a 510(k) decision of Substantially Equivalent on March 6, 1996, 36 days after the submission was received.
What is the product code of K960463?
The FDA product code is GRM – Antisera, All Groups, Salmonella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3550.