Hybrid Capture II Gc-Id
FDA 510(k) K981485 · Digene Corp.
510(k) numberK981485
Submission
- Device name
- Hybrid Capture II Gc-Id
- Applicant
- Digene Corp.
Beltsville, MD, US - Received
- April 24, 1998
- Decision date
- November 29, 1999
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Hologic / Gen-Probe Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K010891 | Modification to Hybrid Capture II Ct/Gc Test, Model 03M90-01LSK · Traditional | 09/25/2001SE |
| K010893 | Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01LSL · Traditional | 09/24/2001SE |
| K010892 | Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01LSK · Traditional | 09/24/2001SE |
| K981567 | Hybrid Capture II Ct/Gc TestLSL · Traditional | 02/29/2000SE |
| K990023 | Hybrid Capture II Ct-Id TestLSK · Traditional | 10/25/1999SE |
| K974901 | Hybrid Capture System CMV DNA AssayLJO · Traditional | 09/29/1998SE |
| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | 02/06/1998SE |
| K971586 | Digene Cervical BrushHHT · Traditional | 09/19/1997SE |
Questions and answers
When was Hybrid Capture II Gc-Id cleared by the FDA?
Hybrid Capture II Gc-Id (K981485) received a 510(k) decision of Substantially Equivalent on November 29, 1999, 584 days after the submission was received.
What is the product code of K981485?
The FDA product code is LSL – Dna-Reagents, Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.3390.