FDA Product Code
FDA Product Code LGL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7500
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K810976 | ALPHA-THAL SCREEN TM CONTROL | Isolab, Inc. | 1981-05-29 | Traditional | PDF ↗ |
| K801771 | ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT | Isolab, Inc. | 1981-01-16 | Traditional | PDF ↗ |
Product code LGL · Class II · Hematology. Data: openFDA.