The following data is part of a premarket notification filed by Abx Diagnostics with the FDA for Abx Micros Crp.
| Device ID | K002646 |
| 510k Number | K002646 |
| Device Name: | ABX MICROS CRP |
| Classification | Counter, Differential Cell |
| Applicant | ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Contact | Bruce Davis |
| Correspondent | Bruce Davis ABX DIAGNOSTICS 34 BUNSEN DR. Irvine, CA 92618 -4210 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-24 |
| Decision Date | 2000-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230004487 | K002646 | 000 |