Accuprobe Streptococcus Pyogenes Culture Confirm.
FDA 510(k) K904268 · Gen-Probe, Inc.
510(k) numberK904268
Submission
- Device name
- Accuprobe Streptococcus Pyogenes Culture Confirm.
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- September 18, 1990
- Decision date
- November 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K924715 | Gen-Probe Direct Group a Streptococus TestMDK · Traditional | Gen-Probe, Inc. | 03/11/1994SE |
| K915852 | Accupace Group a Streptococcus Id TestMDK · Traditional | Gen-Probe, Inc. | 04/02/1992SE |
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| K053446 | Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088MKZ · Traditional | 07/25/2006SE |
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Questions and answers
When was Accuprobe Streptococcus Pyogenes Culture Confirm. cleared by the FDA?
Accuprobe Streptococcus Pyogenes Culture Confirm. (K904268) received a 510(k) decision of Substantially Equivalent on November 13, 1990, 56 days after the submission was received.
What is the product code of K904268?
The FDA product code is MDK – Dna-Probe, Reagents, Streptococcal, a Class I (low risk) device regulated under 21 CFR 866.3740.