FDA Product Code
FDA Product Code LIM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7455
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K980314 | FETAL D TECTION KIT | Biopool Intl., Inc. | 1998-04-08 | Traditional | PDF ↗ |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | Gamma Biologicals, Inc. | 1982-05-12 | Traditional | PDF ↗ |
Product code LIM · Class II · Hematology. Data: openFDA.