The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Dat Multi-drug Low And High Urine Calibrators.
| Device ID | K993954 |
| 510k Number | K993954 |
| Device Name: | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS |
| Classification | Calibrators, Drug Mixture |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 2000-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223298 | K993954 | 000 |
| 15099590223281 | K993954 | 000 |