The following data is part of a premarket notification filed by In Vitro Diagnostics, Inc. with the FDA for 21 Hematology Reagents.
| Device ID | K853304 |
| 510k Number | K853304 |
| Device Name: | 21 HEMATOLOGY REAGENTS |
| Classification | Counter, Differential Cell |
| Applicant | IN VITRO DIAGNOSTICS, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Contact | Jay Mininberg |
| Correspondent | Jay Mininberg IN VITRO DIAGNOSTICS, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-11-12 |