Strepslide
FDA 510(k) K882811 · Ncs Diagnostics, Inc.
510(k) numberK882811
Submission
- Device name
- Strepslide
- Applicant
- Ncs Diagnostics, Inc.
Mississauga, L4z 1y6, CA - Received
- July 7, 1988
- Decision date
- October 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K943499 | Kultsure STARSWAB(M240), ModificationJSM · Traditional | 11/30/1994SE |
| K943498 | Kultsure Starswab (M210), ModificationJSM · Traditional | 11/30/1994SE |
| K881209 | Aso Slide TestGTQ · Traditional | 04/12/1988SE |
| K874019 | StaphslideJWX · Traditional | 10/28/1987SE |
| K871404 | KultsureJSM · Traditional | 04/21/1987SE |
| K870231 | KultsureLIO · Traditional | 02/04/1987SE |
| K860178 | Kultsure (Culture Transport)JSM · Traditional | 04/04/1986SE |
| K860655 | Kultsure (Catalogue No. M200)LIO · Traditional | 03/06/1986SE |
| K860658 | Kultsure (Catalogue No. M250)JSM · Traditional | 03/04/1986SE |
| K860657 | Kultsure (Catalogue No. M240)JSM · Traditional | 03/04/1986SE |
Questions and answers
When was Strepslide cleared by the FDA?
Strepslide (K882811) received a 510(k) decision of Substantially Equivalent on October 25, 1988, 110 days after the submission was received.
What is the product code of K882811?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.