The following data is part of a premarket notification filed by Drew Scientific, Inc. with the FDA for D3 Hematology Analyzer, Model D3.
| Device ID | K071562 |
| 510k Number | K071562 |
| Device Name: | D3 HEMATOLOGY ANALYZER, MODEL D3 |
| Classification | Counter, Differential Cell |
| Applicant | DREW SCIENTIFIC, INC. 4230 SHILLING WAY Dallas, TX 75237 |
| Contact | Roger Bourree |
| Correspondent | Roger Bourree DREW SCIENTIFIC, INC. 4230 SHILLING WAY Dallas, TX 75237 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-07 |
| Decision Date | 2007-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274021491 | K071562 | 000 |