The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Drug Calibrator 2.
| Device ID | K993473 |
| 510k Number | K993473 |
| Device Name: | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 |
| Classification | Calibrators, Drug Specific |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Gail Lefebvre |
| Correspondent | Gail Lefebvre BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-14 |
| Decision Date | 1999-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590200039 | K993473 | 000 |