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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2025 | Illumina, Inc. Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument:
NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20 Open, Classified |
PFT | None listed |
| Apr 26, 2018 | Horiba Instruments, Inc dba Horiba Medical ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563
The device is intended for use in conjunction with certain materials to measure a variety of analytes. Terminated |
PFT | None listed |
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