IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

Lipoprotein, Low-density, Antigen, Antiserum, Control

BECKMAN COULTER, INC.

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590575137	K000121	000
15099590221171	K000121	000