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 |