Panels › Microbiology › Product code MDK · Class 1
Dna-Probe, Reagents, Streptococcal
Regulation 866.3740
0510(k)s in 12 months (4 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MDK
| Company | 510(k)s | Recalls |
|---|---|---|
| Gen-Probe, Inc. | 3 | 2 |
| Chugai Pharmaceuticals Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2011 | Gen-Probe Inc Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820. Terminated |
MDK | K974572 |
| Dec 19, 2007 | Gen-Probe Inc Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121 Terminated |
MDK | K974572 |
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