The following data is part of a premarket notification filed by Biowhittaker Molecular Applications, Inc. with the FDA for Rheumelisa Ii Scl-70 Antibody Test Kit.
| Device ID | K930130 |
| 510k Number | K930130 |
| Device Name: | RHEUMELISA II SCL-70 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 E Olsen |
| Correspondent | Leif E 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 | 1993-01-12 |
| Decision Date | 1993-03-23 |