The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Hematology-16 Control, Low, Normal And High.
| Device ID | K942209 |
| 510k Number | K942209 |
| Device Name: | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH |
| Classification | Control, Cell Counter, Normal And Abnormal |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Donna Chapman |
| Correspondent | Donna Chapman BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | JCN |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-05 |
| Decision Date | 1994-06-16 |