UPRO

Turbidimetric, Total Protein

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Upro.

Pre-market Notification Details

• Device ID: K981682
• 510k Number: K981682
• Device Name: UPRO
• Classification: Turbidimetric, Total Protein
• Applicant: ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038
• Contact: Mark Littlefield
• Correspondent: Mark Littlefield; ABBOTT LABORATORIES DEPT. 09VA LC-2 1920 HURD DRIVE Irving, TX 75038
• Product Code: JGQ
• CFR Regulation Number: 862.1635 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-13
• Decision Date: 1998-09-21
• Summary: summary