FDA Product Code
FDA Product Code GJR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080016 | NRBC-CHEX FOR ADVIA | Streck | 2008-02-05 | Traditional | PDF ↗ |
| K060083 | NRBC-CHEX FOR LH | Streck | 2006-02-09 | Traditional | PDF ↗ |
| K000076 | CELL-CHEX | Streck Laboratories, Inc. | 2000-03-03 | Traditional | PDF ↗ |
| K940430 | SEDRATROL | Medical Specialties Intl., Inc. | 1995-02-06 | Traditional | PDF ↗ |
| K900484 | RET-CHECK | Streck Laboratories, Inc. | 1990-03-09 | Traditional | PDF ↗ |
Product code GJR · Class II · Hematology. Data: openFDA.