Pace 2 System for Chlamydia Trachomatis
FDA 510(k) K920378 · Gen-Probe, Inc.
510(k) numberK920378
Submission
- Device name
- Pace 2 System for Chlamydia Trachomatis
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- January 29, 1992
- Decision date
- April 29, 1992
- 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 |
| K010892 | Modification Hybrid Capture II Ct-Id DNA Test, Model 03M91-01LSK · Traditional | Digene Corp. | 09/24/2001SE |
| 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 |
| 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 |
|---|---|---|
| K122062 | Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional | 01/09/2013SE |
| K111409 | Aptima Combo 2 AssayLSL · Traditional | 05/03/2012SE |
| K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae MODEL#1091LSL · Traditional | 01/25/2007SE |
| K063451 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1199MKZ · Traditional | 01/22/2007SE |
| K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091LSL · Traditional | 11/07/2006SE |
| K061413 | Aptima CT Assay on the Tigris DTS SystemMKZ · Traditional | 10/13/2006SE |
| K061509 | Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196LSL · Traditional | 10/04/2006SE |
| K060652 | Tigris DTS Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/17/2006SE |
| K053446 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088MKZ · Traditional | 07/25/2006SE |
| K043224 | Gen-Probe Aptima Combo 2 AssayLSL · Traditional | 08/09/2005SE |
Questions and answers
When was Pace 2 System for Chlamydia Trachomatis cleared by the FDA?
Pace 2 System for Chlamydia Trachomatis (K920378) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 91 days after the submission was received.
What is the product code of K920378?
The FDA product code is LSK – Dna-Reagents, Chlamydia, a Class I (low risk) device regulated under 21 CFR 866.3120.