The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Protein Strandard Sl.
Device ID | K964062 |
510k Number | K964062 |
Device Name: | N PROTEIN STRANDARD SL |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Laura Lebarron |
Correspondent | Laura Lebarron 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 | 1996-10-10 |
Decision Date | 1996-11-21 |
Summary: | summary |