The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Immunochemistry System Lipoprotein(a) Lpax Reagent, Array System Lipoprotein(a) Lpa Reagent, Lipoprotein(a) Calib.
| Device ID | K000121 |
| 510k Number | K000121 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590575137 | K000121 | 000 |
| 15099590221171 | K000121 | 000 |