The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Protein Control Sl.
Device ID | K964065 |
510k Number | K964065 |
Device Name: | N/T PROTEIN CONTROL SL |
Classification | Multi-analyte Controls, All Kinds (assayed) |
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 | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-10 |
Decision Date | 1996-11-06 |
Summary: | summary |