The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Tech-cal(tm)/multiple.
| Device ID | K881161 |
| 510k Number | K881161 |
| Device Name: | TECH-CAL(TM)/MULTIPLE |
| Classification | Calibrator For Red-cell And White-cell Counting |
| Applicant | R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Contact | Karen Viskochil |
| Correspondent | Karen Viskochil R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. Minneapolis, MN 55413 |
| Product Code | KSA |
| CFR Regulation Number | 864.8185 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-05-02 |