The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Acetaminophen (actm) Reagent.
| Device ID | K000494 |
| 510k Number | K000494 |
| Device Name: | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT |
| Classification | Colorimetry, Acetaminophen |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Gail Lefebvre |
| Correspondent | Gail Lefebvre BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | LDP |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590229962 | K000494 | 000 |