Panels › Clinical Chemistry › Product code PFT · Class 1
Reagents For Molecular Diagnostic Test Systems
Regulation 862.3800
0510(k)s in 12 months (1 all time)
1recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in PFT
| Company | 510(k)s | Recalls |
|---|---|---|
| Illumina, Inc. | 1 | 1 |
| Horiba Instruments, Inc dba Horiba Medical | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2013 | DEN130042 | MISEQDX UNIVERSAL KIT 1.0 Illumina, Inc. | PFT |
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