The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Microalbumin (ma) Reagent, Model 475100.
| Device ID | K082251 |
| 510k Number | K082251 |
| Device Name: | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. MS 110 Brea, CA 92821 |
| Contact | Marine Boyajian |
| Correspondent | Marine Boyajian BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. MS 110 Brea, CA 92821 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2009-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590225339 | K082251 | 000 |