FDA Product Code
FDA Product Code JCN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8625
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993825 | PARA TECH PLUS RETICS | Streck Laboratories, Inc. | 1999-11-30 | Traditional | PDF ↗ |
| K942209 | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | Bio-Rad | 1994-06-16 | Traditional | PDF ↗ |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1993-12-06 | Traditional | PDF ↗ |
| K911582 | STAK-CHEX | Streck Laboratories, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K902391 | CELL-DYN 3000 CONTROL | Unipath , Ltd. | 1990-08-22 | Traditional | PDF ↗ |
| K902389 | TRI-COUNT 16 | Hematronix, Inc. | 1990-08-22 | Traditional | PDF ↗ |
| K901875 | PARA 12 PLUS | Streck Laboratories, Inc. | 1990-05-30 | Traditional | PDF ↗ |
| K896154 | PARA TECH FOR TECHNICON H-1 | Streck Laboratories, Inc. | 1989-11-09 | Traditional | PDF ↗ |
| K895373 | HEMATOLOGY CONTROL | Medical Specialties Intl., Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K891907 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED | R&D Systems, Inc. | 1989-04-11 | Traditional | PDF ↗ |
| K874386 | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | Baker Instructions Corp. | 1982-07-30 | Traditional | PDF ↗ |
Product code JCN · Class II · Hematology. Data: openFDA.