The following data is part of a premarket notification filed by Diatron Us Inc with the FDA for Abacus 5.
| Device ID | K112755 |
| 510k Number | K112755 |
| Device Name: | ABACUS 5 |
| Classification | Counter, Differential Cell |
| Applicant | DIATRON US INC 14026 W. 107TH STREET Lenexa, KS 66215 -2005 |
| Contact | Michael Switzer |
| Correspondent | Michael Switzer DIATRON US INC 14026 W. 107TH STREET Lenexa, KS 66215 -2005 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-21 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414601816 | K112755 | 000 |
| 00630414601298 | K112755 | 000 |
| 00630414601281 | K112755 | 000 |