The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Immunop. Antismooth Muscle Antibody Kit.
| Device ID | K800228 |
| 510k Number | K800228 |
| Device Name: | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT |
| Classification | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBE |
| CFR Regulation Number | 866.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-05 |
| Decision Date | 1980-02-21 |