The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems 10 Ng/ml & 40 Ng/ml Thc Urine Controls.
| Device ID | K971210 |
| 510k Number | K971210 |
| Device Name: | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS |
| Classification | Drug Specific Control Materials |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Frank Marte |
| Correspondent | Frank Marte BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223434 | K971210 | 000 |
| 15099590223427 | K971210 | 000 |