FDA Product Code
FDA Product Code DAQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5540
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K891299 | MID-LEVEL IGG KIT CAT. NO. 9315 | Helena Laboratories | 1989-03-22 | Traditional | PDF ↗ |
Product code DAQ · Class I · Immunology. Data: openFDA.