The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Laser Nephelometer.
Device ID | K761234 |
510k Number | K761234 |
Device Name: | BEHRING LASER NEPHELOMETER |
Classification | Nephelometer |
Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Product Code | JZW |
CFR Regulation Number | 866.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-07 |
Decision Date | 1990-06-07 |