FDA Product Code
FDA Product Code GIG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7500
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K973995 | RANDOX BILIRUBIN | Randox Laboratories, Ltd. | 1997-12-08 | Traditional | PDF ↗ |
| K933836 | HBM HEMOGLOBINOMETER | Artel, Inc. | 1994-03-31 | Traditional | PDF ↗ |
| K771101 | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET | The Dow Chemical Co. | 1977-07-21 | Traditional | PDF ↗ |
Product code GIG · Class II · Hematology. Data: openFDA.