Abbott Realtime Ct/Ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03
FDA 510(k) K092704 · Abbott Molecular, Inc.
510(k) numberK092704
Submission
- Device name
- Abbott Realtime Ct/Ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03
- Applicant
- Abbott Molecular, Inc.
Des Plaines, IL, US - Received
- September 3, 2009
- Decision date
- May 28, 2010
- 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Abbott Realtime Ct/Ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03 cleared by the FDA?
Abbott Realtime Ct/Ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03 (K092704) received a 510(k) decision of Substantially Equivalent on May 28, 2010, 267 days after the submission was received.
What is the product code of K092704?
The FDA product code is LSK – Dna-Reagents, Chlamydia, a Class I (low risk) device regulated under 21 CFR 866.3120.