The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Pentra 5d.
| Device ID | K003534 |
| 510k Number | K003534 |
| Device Name: | PENTRA 5D |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Kenneth T Edds |
| Correspondent | Kenneth T Edds R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2000-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590639419 | K003534 | 000 |