The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Op 300 Low And High Urine Controls.
| Device ID | K993023 |
| 510k Number | K993023 |
| Device Name: | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Gail L Efebvre |
| Correspondent | Gail L Efebvre BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-09 |
| Decision Date | 1999-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222000 | K993023 | 000 |
| 15099590221997 | K993023 | 000 |