The following data is part of a premarket notification filed by Biowhittaker Molecular Applications, Inc. with the FDA for Rf Stat Igm Test Kit.
Device ID | K920753 |
510k Number | K920753 |
Device Name: | RF STAT IGM TEST KIT |
Classification | System, Test, Rheumatoid Factor |
Applicant | BIOWHITTAKER MOLECULAR APPLICATIONS, INC. 8830 BIGGS FORD RD. Walkersville, MD 21793 -0127 |
Contact | Leif E Olsen |
Correspondent | Leif E Olsen BIOWHITTAKER MOLECULAR APPLICATIONS, INC. 8830 BIGGS FORD RD. Walkersville, MD 21793 -0127 |
Product Code | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-19 |
Decision Date | 1992-03-30 |