The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Alcohol Reagent And Calibrators.
| Device ID | K000410 |
| 510k Number | K000410 |
| Device Name: | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS |
| Classification | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | DMT |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223335 | K000410 | 000 |
| 15099590222079 | K000410 | 000 |