The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for R & D 4k Retic.
| Device ID | K010470 |
| 510k Number | K010470 |
| Device Name: | R & D 4K RETIC |
| 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 | 2001-02-20 |
| Decision Date | 2001-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003793 | K010470 | 000 |
| 00847661003786 | K010470 | 000 |
| 00847661003779 | K010470 | 000 |