FDA Product Code
FDA Product Code NQM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1550
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110605 | ROM PLUS | Clinical Innovations, LLC | 2011-11-23 | Traditional | PDF ↗ |
| K081767 | AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 | Amnisure International, LLC | 2009-01-09 | Traditional | PDF ↗ |
Product code NQM · Class I · Clinical Chemistry. Data: openFDA.