The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Beckman Coulter Dnase B Calibrator.
| Device ID | K010696 |
| 510k Number | K010696 |
| Device Name: | BECKMAN COULTER DNASE B CALIBRATOR |
| Classification | Calibrator, Primary |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Richard T Ross |
| Correspondent | Richard T Ross BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-05-10 |