The following data is part of a premarket notification filed by Biochem Immunosystems (u.s.), Inc. with the FDA for Spirit Hematology System Model Le, Cp, & Ax.
| Device ID | K960072 |
| 510k Number | K960072 |
| Device Name: | SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX |
| Classification | Counter, Differential Cell |
| Applicant | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 1151 HOPE ST. Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 1151 HOPE ST. Stamford, CT 06907 |
| Product Code | GKZ |
| Subsequent Product Code | GKL |
| Subsequent Product Code | GKX |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-05 |
| Decision Date | 1997-03-06 |
| Summary: | summary |