The following data is part of a premarket notification filed by Beckman with the FDA for Synchron Syustems Dat Drug Free Urine Control.
| Device ID | K971534 |
| 510k Number | K971534 |
| Device Name: | SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | BECKMAN 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92621 |
| Contact | Frank Marte |
| Correspondent | Frank Marte BECKMAN 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92621 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590180225 | K971534 | 000 |