Gen-Probe Direct Group a Streptococus Test
FDA 510(k) K924715 · Gen-Probe, Inc.
510(k) numberK924715
Submission
- Device name
- Gen-Probe Direct Group a Streptococus Test
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- September 21, 1992
- Decision date
- March 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDK – Dna-Probe, Reagents, Streptococcal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code MDK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974572 | Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820MDK · Traditional | Chugai Pharmaceuticals Co., Ltd. | 09/24/1998SE |
| K915852 | Accupace Group a Streptococcus Id TestMDK · Traditional | Gen-Probe, Inc. | 04/02/1992SE |
| K904268 | Accuprobe Streptococcus Pyogenes Culture Confirm.MDK · Traditional | Gen-Probe, Inc. | 11/13/1990SE |
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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 Gen-Probe Direct Group a Streptococus Test cleared by the FDA?
Gen-Probe Direct Group a Streptococus Test (K924715) received a 510(k) decision of Substantially Equivalent on March 11, 1994, 536 days after the submission was received.
What is the product code of K924715?
The FDA product code is MDK – Dna-Probe, Reagents, Streptococcal, a Class I (low risk) device regulated under 21 CFR 866.3740.