Panels › Clinical Chemistry › Product code NQM · Class 1
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Regulation 862.1550
0510(k)s in 12 months (2 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in NQM
| Company | 510(k)s | Recalls |
|---|---|---|
| Clinical Innovations, LLC | 1 | 1 |
| Qiagen Sciences LLC | 0 | 2 |
| Amnisure International, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2011 | K110605 | ROM PLUS Clinical Innovations, LLC | NQM |
| Jan 9, 2009 | K081767 | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 Amnisure International, LLC | NQM |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.