The following data is part of a premarket notification filed by R & D Systems, Inc. with the FDA for Cd-cal Plus Calibrator.
| Device ID | K003991 |
| 510k Number | K003991 |
| Device Name: | CD-CAL PLUS CALIBRATOR |
| Classification | Calibrator For Cell Indices |
| 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 | KRX |
| Subsequent Product Code | KRY |
| Subsequent Product Code | KRZ |
| Subsequent Product Code | KSA |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817274020258 | K003991 | 000 |
| 20815762020937 | K003991 | 000 |