Panels › Microbiology › Product code OAH · Class 1
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Regulation 866.3740
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OAH
| Company | 510(k)s | Recalls |
|---|---|---|
| Advandx, Inc. | 4 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2013 | K121991 | ENTEROCOCCUS QUICKFISH BC Advandx, Inc. | OAH |
| Jul 24, 2009 | K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT Advandx, Inc. | OAH |
| May 5, 2009 | K082612 | GBS PNA FISH Advandx, Inc. | OAH |
| Dec 22, 2006 | K063127 | ENTEROCOCCUS FAECALIS PNA FISH Advandx, Inc. | OAH |
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