FDA Product Code
FDA Product Code CGM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K915650 | HUMAN IGG SUBCLASS RID KIT | Janssen Biochimica | 1992-03-26 | Traditional | PDF ↗ |
| K920006 | IL TEST IMMUNOGLOBULIN G (IGG) | Instrumentation Laboratory CO | 1992-03-13 | Traditional | PDF ↗ |
| K920008 | IL TEST IMMUNOGLOBULIN M (IGM) | Instrumentation Laboratory CO | 1992-03-11 | Traditional | PDF ↗ |
| K920370 | ISOTYPES HUMAN IGG SUBCLASS EIA KIT | Isotypes, Inc. | 1992-03-11 | Traditional | PDF ↗ |
Product code CGM · Class II · Immunology. Data: openFDA.