The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cbc-line Hematology Linearity Control.
| Device ID | K942822 |
| 510k Number | K942822 |
| Device Name: | CBC-LINE HEMATOLOGY LINEARITY CONTROL |
| Classification | Mixture, Hematology Quality Control |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Sue Gallo |
| Correspondent | Sue Gallo 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 | 1994-06-15 |
| Decision Date | 1994-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815762021954 | K942822 | 000 |
| 00815762020742 | K942822 | 000 |
| 00815762020735 | K942822 | 000 |
| 00815762020728 | K942822 | 000 |
| 00815762020711 | K942822 | 000 |
| 00815762020698 | K942822 | 000 |
| 00815762020681 | K942822 | 000 |
| 00815762020667 | K942822 | 000 |
| 00815762020650 | K942822 | 000 |
| 00815762020643 | K942822 | 000 |
| 00815762020636 | K942822 | 000 |
| 00815762020629 | K942822 | 000 |
| 00815762020612 | K942822 | 000 |
| 00815762020599 | K942822 | 000 |
| 00815762020582 | K942822 | 000 |
| 00815762020575 | K942822 | 000 |
| 00815762020568 | K942822 | 000 |
| 00815762020551 | K942822 | 000 |
| 00815762020759 | K942822 | 000 |
| 00815762021183 | K942822 | 000 |
| 00815762021947 | K942822 | 000 |
| 00815762021930 | K942822 | 000 |
| 00815762021923 | K942822 | 000 |
| 00815762021862 | K942822 | 000 |
| 00815762021855 | K942822 | 000 |
| 00815762021848 | K942822 | 000 |
| 00815762021831 | K942822 | 000 |
| 00815762021824 | K942822 | 000 |
| 00815762021817 | K942822 | 000 |
| 00815762021800 | K942822 | 000 |
| 00815762021794 | K942822 | 000 |
| 00815762021787 | K942822 | 000 |
| 00815762021770 | K942822 | 000 |
| 00815762021763 | K942822 | 000 |
| 00815762021626 | K942822 | 000 |
| 00815762021619 | K942822 | 000 |
| 00815762021190 | K942822 | 000 |
| 00815762026508 | K942822 | 000 |