The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Hct Extended Hematology Control, Model Hct004.
| Device ID | K073178 |
| 510k Number | K073178 |
| Device Name: | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Nancy C Ring |
| Correspondent | Nancy C Ring 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 | 2007-11-13 |
| Decision Date | 2007-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021046 | K073178 | 000 |