The following data is part of a premarket notification filed by Contraves Medical Instruments, Inc. with the FDA for Autolyzer 801 System (automated Cell Counter).
| Device ID | K875346 |
| 510k Number | K875346 |
| Device Name: | AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) |
| Classification | Counter, Differential Cell |
| Applicant | CONTRAVES MEDICAL INSTRUMENTS, INC. 44 MANNING RD. Billerica, MA 01821 |
| Contact | David Bertolami |
| Correspondent | David Bertolami CONTRAVES MEDICAL INSTRUMENTS, INC. 44 MANNING RD. Billerica, MA 01821 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-04-07 |