BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST

Biuret (colorimetric), Total Protein

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Synchron(tm) (micro) Total Protein Test.

Pre-market Notification Details

• Device ID: K914885
• 510k Number: K914885
• Device Name: BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST
• Classification: Biuret (colorimetric), Total Protein
• Applicant: BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000
• Contact: William T Ryan
• Correspondent: William T Ryan; BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000
• Product Code: CEK
• CFR Regulation Number: 862.1635 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-10-30
• Decision Date: 1992-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590229825	K914885	000