The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Chromotimer.
Device ID | K901829 |
510k Number | K901829 |
Device Name: | BEHRING CHROMOTIMER |
Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Contact | John E Hughes |
Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Product Code | JJQ |
CFR Regulation Number | 862.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-24 |
Decision Date | 1990-07-24 |