SAS Shigella Boydii Type 13 Antiserum
FDA 510(k) K961531 · Sa Scientific, Inc.
510(k) numberK961531
Submission
- Device name
- SAS Shigella Boydii Type 13 Antiserum
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- April 22, 1996
- Decision date
- May 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GNB – Antisera, All Types, Shigella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3660
- Specialty
- Microbiology
Other 510(k)s with product code GNB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961537 | SAS Shigella Sonnei Form II AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/31/1996SE |
| K961559 | SAS Shigella Dysenteriae Type 9 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961558 | SAS Shigella Flexneri Type 3 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961556 | SAS Shigella Flexneri Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961554 | SAS Shigella Boydii Type 10 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961553 | SAS Shigella Dysenteriae Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961551 | SAS Shigella Dysenteriae Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961549 | SAS Shigella Flexneri Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961548 | SAS Shigella Boydii Type 15 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961547 | SAS Shigella Boydii Type 14 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
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 Shigella Boydii Type 13 Antiserum cleared by the FDA?
SAS Shigella Boydii Type 13 Antiserum (K961531) received a 510(k) decision of Substantially Equivalent on May 20, 1996, 28 days after the submission was received.
What is the product code of K961531?
The FDA product code is GNB – Antisera, All Types, Shigella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3660.