Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820
FDA 510(k) K974572 · Chugai Pharmaceuticals Co., Ltd.
510(k) numberK974572
Submission
- Device name
- Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820
- Applicant
- Chugai Pharmaceuticals Co., Ltd.
San Diego, CA, US - Received
- December 5, 1997
- Decision date
- September 24, 1998
- 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 |
|---|---|---|---|
| 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 |
| K904268 | Accuprobe Streptococcus Pyogenes Culture Confirm.MDK · Traditional | Gen-Probe, Inc. | 11/13/1990SE |
Questions and answers
When was Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820 cleared by the FDA?
Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820 (K974572) received a 510(k) decision of Substantially Equivalent on September 24, 1998, 293 days after the submission was received.
What is the product code of K974572?
The FDA product code is MDK – Dna-Probe, Reagents, Streptococcal, a Class I (low risk) device regulated under 21 CFR 866.3740.