FDA Product Code
FDA Product Code KJR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1850
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K842834 | HEP-2 CELLS | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K792546 | FETAL CHECK | Alta Diagnostics, Inc. | 1979-12-18 | Traditional | PDF ↗ |
Product code KJR · Class I · Hematology. Data: openFDA.