The following data is part of a premarket notification filed by Biostar Medical Products, Inc. with the FDA for Biostar Re-a-ds Immune Complex Assay Kit.
| Device ID | K853697 |
| 510k Number | K853697 |
| Device Name: | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | BIOSTAR MEDICAL PRODUCTS, INC. JERRY W. BERKSTRESSER 738 PEARL STREET Denver, CO 80203 |
| Contact | Jerry W Berkstresse |
| Correspondent | Jerry W Berkstresse BIOSTAR MEDICAL PRODUCTS, INC. JERRY W. BERKSTRESSER 738 PEARL STREET Denver, CO 80203 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-04 |
| Decision Date | 1985-12-16 |