The following data is part of a premarket notification filed by Biowhittaker Molecular Applications, Inc. with the FDA for Rheumelisa Ii Jo-1 Antibody Test Kit.
Device ID | K930757 |
510k Number | K930757 |
Device Name: | RHEUMELISA II JO-1 ANTIBODY TEST KIT |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
Applicant | BIOWHITTAKER MOLECULAR APPLICATIONS, INC. 8830 BIGGS FORD RD. Walkersville, MD 21793 -0127 |
Contact | Leif Olsen |
Correspondent | Leif Olsen BIOWHITTAKER MOLECULAR APPLICATIONS, INC. 8830 BIGGS FORD RD. Walkersville, MD 21793 -0127 |
Product Code | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-12 |
Decision Date | 1993-03-26 |