BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA Assay
FDA 510(k) K090971 · Becton, Dickinson & CO
510(k) numberK090971
Submission
- Device name
- BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA Assay
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- April 6, 2009
- Decision date
- June 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSL – Dna-Reagents, Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code LSL
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|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae AssayLSL · Traditional | Hologic, Inc. | 01/26/2024SE |
| K180681 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic, Inc. | 06/13/2018SE |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systemsLSL · Traditional | Roche Molecular Systems, Inc. | 03/21/2018SE |
| K173840 | Xpert CT/NGLSL · Traditional | Cepheid | 03/16/2018SE |
| K163184 | cobas® CT/NG v2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 02/09/2017SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | Becton, Dickinson & CO | 05/20/2014SE |
| K140354 | Abbott Multi-Collect Specimen Collection Kit, Abbott Real Time Ct/NgLSL · Traditional | Abbott Molecular, Inc. | 05/09/2014SE |
| K140887 | Cobas Ct/Ng V2.0 TestLSL · Special | Roche Molecular Systems, Inc. | 05/05/2014SE |
| K132270 | Cobas Ct/Ng V2.0 TestLSL · Traditional | Roche Molecular Systems, Inc. | 12/02/2013SE |
| K132251 | Aptima Combo 2 Assay (Panther System)LSL · Traditional | Hologic / Gen-Probe Incorporated | 10/17/2013SE |
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| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/20/2014SE |
Questions and answers
When was BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA Assay cleared by the FDA?
BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA Assay (K090971) received a 510(k) decision of Substantially Equivalent on June 5, 2009, 60 days after the submission was received.
What is the product code of K090971?
The FDA product code is LSL – Dna-Reagents, Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.3390.