Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01
FDA 510(k) K010892 · Digene Corp.
510(k) numberK010892
Submission
- Device name
- Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01
- Applicant
- Digene Corp.
Gaithersburg, MD, US - Received
- March 26, 2001
- Decision date
- September 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LSK – Dna-Reagents, Chlamydia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Specialty
- Microbiology
Other 510(k)s with product code LSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092704 | Abbott Realtime Ct/Ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…LSK · Traditional | Abbott Molecular, Inc. | 05/28/2010SE |
| K010891 | Modification to Hybrid Capture II Ct/Gc Test, Model 03M90-01LSK · Traditional | Digene Corp. | 09/25/2001SE |
| K990023 | Hybrid Capture II Ct-Id TestLSK · Traditional | Digene Corp. | 10/25/1999SE |
| K920302 | Pace 2 Chlamydia Trachomatis Probe Confirm AssayLSK · Traditional | Gen-Probe, Inc. | 04/06/1994SE |
| K920378 | Pace 2 System for Chlamydia TrachomatisLSK · Traditional | Gen-Probe, Inc. | 04/29/1992SE |
| K874878 | Gen-Probe(R) Pace(Tm) System Chlamydia TrachomatisLSK · Traditional | Gen-Probe, Inc. | 12/29/1987SE |
| K871878 | Rapid Diagnostic System for Chlamydia TrachomatisLSK · Traditional | Gen-Probe, Inc. | 10/28/1987SE |
More from Gen-Probe, Inc.
| 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 |
| K981567 | Hybrid Capture II Ct/Gc TestLSL · Traditional | 02/29/2000SE |
| K981485 | Hybrid Capture II Gc-IdLSL · Traditional | 11/29/1999SE |
| 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 Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01 cleared by the FDA?
Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01 (K010892) received a 510(k) decision of Substantially Equivalent on September 24, 2001, 182 days after the submission was received.
What is the product code of K010892?
The FDA product code is LSK – Dna-Reagents, Chlamydia, a Class I (low risk) device regulated under 21 CFR 866.3120.