Biostrep a, Biosign Strep a, Statusfirst Strep a
FDA 510(k) K082661 · Princeton BioMeditech Corp.
510(k) numberK082661
Submission
- Device name
- Biostrep a, Biosign Strep a, Statusfirst Strep a
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- September 12, 2008
- Decision date
- October 6, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K051638 | Inverness Medical Testpack + Plus Strep a with ObcGTY · Traditional | Unipath , Ltd. | 12/06/2005SE |
More from Unipath , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251538 | Status COVID-19/Flu A&BSCA · Dual Track | 11/14/2025SE |
| K182157 | BioSign Flu A+BPSZ · Special | 09/18/2018SE |
| K130650 | Status DS OxyDJG · Traditional | 02/26/2014SE |
| K133474 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 12/10/2013SE |
| K132465 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 09/09/2013SE |
| K083746 | Biosign Flu A+BPSZ · Traditional | 11/10/2010SE |
| K100817 | Biosign Ifobtest, Biosign Fecal Occult Blood TestKHE · Traditional | 07/01/2010SE |
| K100341 | Spermcheck FertilityPOV · Traditional | 05/04/2010SE |
| K073039 | Spermcheck VasectomyPOV · Traditional | 01/24/2008SE |
| K062575 | Modification to: Accusign RC Doa 10 (Met/Opi/Coc/Thc/Pcp/Bzo/Bar/Mtd/Tca/AmpLAG · Traditional | 11/26/2007SE |
Questions and answers
When was Biostrep a, Biosign Strep a, Statusfirst Strep a cleared by the FDA?
Biostrep a, Biosign Strep a, Statusfirst Strep a (K082661) received a 510(k) decision of Substantially Equivalent on October 6, 2008, 24 days after the submission was received.
What is the product code of K082661?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.