The following data is part of a premarket notification filed by Biostar Medical Products, Inc. with the FDA for Biostar* Reads* Immune Complex Assay Kit.
| Device ID | K861499 |
| 510k Number | K861499 |
| Device Name: | BIOSTAR* READS* 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 | & Law |
| Correspondent | & Law 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 | 1986-04-23 |
| Decision Date | 1986-06-20 |