Accuprobe Mycobacterium Kansasii Cult Confirm Test
FDA 510(k) K904463 · Gen-Probe, Inc.
510(k) numberK904463
Submission
- Device name
- Accuprobe Mycobacterium Kansasii Cult Confirm Test
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- October 1, 1990
- Decision date
- November 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQF – Dna-Reagents, Mycobacterium Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3370
- Specialty
- Microbiology
Other 510(k)s with product code LQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921435 | Accuprobe Mycobacterium Avium Complex CultureLQF · Traditional | Gen-Probe, Inc. | 07/23/1992SE |
| K897077 | Accuprobe Mycobacterium Intracellulare CultureLQF · Traditional | Gen-Probe, Inc. | 08/23/1990SE |
| K896494 | Accuprobe Mycobacterium Avium Culture TestLQF · Traditional | Gen-Probe, Inc. | 08/23/1990SE |
| K897078 | Accuprobe Mycobacterium Avium Complex CultureLQF · Traditional | Gen-Probe, Inc. | 05/02/1990SE |
| K896492 | Accuprobe Mycobacterium Gordonae Culture TestLQF · Traditional | Gen-Probe, Inc. | 04/16/1990SE |
| K896493 | Accuprobe Mycobacterium Tuberculosis Complex TestLQF · Traditional | Gen-Probe, Inc. | 04/11/1990SE |
| K900292 | Snap M. Tuberculosis ComplexLQF · Traditional | Syngene, Inc. | 04/03/1990SE |
| K900202 | Snap Mycobacteria Avium ComplexLQF · Traditional | Syngene, Inc. | 04/03/1990SE |
| K890089 | Rapid Diag. System for Mycobacterium GordonaeLQF · Traditional | Gen-Probe, Inc. | 03/13/1989SE |
| K871795 | Rapid Diagnostic System for Mycobacterium Tuber.LQF · Traditional | Gen-Probe, Inc. | 07/30/1987SE |
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| 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 Accuprobe Mycobacterium Kansasii Cult Confirm Test cleared by the FDA?
Accuprobe Mycobacterium Kansasii Cult Confirm Test (K904463) received a 510(k) decision of Substantially Equivalent on November 13, 1990, 43 days after the submission was received.
What is the product code of K904463?
The FDA product code is LQF – Dna-Reagents, Mycobacterium Spp., a Class I (low risk) device regulated under 21 CFR 866.3370.