N PROTEIN STANDARD PY

Calibrator, Multi-analyte Mixture

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Protein Standard Py.

Pre-market Notification Details

• Device ID: K962410
• 510k Number: K962410
• Device Name: N PROTEIN STANDARD PY
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090
• Contact: Kathleen Dray-lyons
• Correspondent: Kathleen Dray-lyons; BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-06-21
• Decision Date: 1996-07-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768021114	K962410	000