The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Turbiquant Myoglobin.
Device ID | K903687 |
510k Number | K903687 |
Device Name: | TURBIQUANT MYOGLOBIN |
Classification | Myoglobin, Antigen, Antiserum, Control |
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 | DDR |
CFR Regulation Number | 866.5680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-15 |
Decision Date | 1990-10-16 |