SAS Strepalert
FDA 510(k) K023270 · Sa Scientific, Inc.
510(k) numberK023270
Submission
- Device name
- SAS Strepalert
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- October 1, 2002
- Decision date
- October 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260342 | AllTest Strep A Rapid TestGTY · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/30/2026SE |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY · Dual Track | ACON Laboratories, Inc. | 11/26/2025SE |
| K212623 | Healgen Strep A Rapid Test Strip (Throat Swab)GTY · Traditional | Healgen Scientific,, LLC | 03/16/2022SE |
| K171976 | Sofia Strep A+ FIA, Sofia 2 AnalyzerGTY · Dual Track | Quidel Corporation | 12/21/2017SE |
| K141775 | Sofia (R) Strep A+ FiaGTY · Dual Track | Quidel Corporation | 12/16/2014SE |
| K133343 | Wondfo Rapid Strep a TestGTY · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/31/2014SE |
| K123793 | Sofia Strep a FiaGTY · Traditional | Quidel Corporation | 06/17/2013SE |
| K122718 | BD Veritor(Tm) System for Rapid Detection of Group a StrepGTY · Traditional | Becton, Dickinson and Company | 02/06/2013SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | Binax, Inc. | 09/04/2009SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | Princeton BioMeditech Corp. | 10/06/2008SE |
More from Princeton BioMeditech Corp.
| 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 |
| K020438 | SAS Value HCGJHI · Abbreviated | 03/08/2002SE |
Questions and answers
When was SAS Strepalert cleared by the FDA?
SAS Strepalert (K023270) received a 510(k) decision of Substantially Equivalent on October 17, 2002, 16 days after the submission was received.
What is the product code of K023270?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.