The following data is part of a premarket notification filed by Biostar Medical Products, Inc. with the FDA for Semi-quantitative Assay For Det. Of Igg And Igm.
| Device ID | K893897 |
| 510k Number | K893897 |
| Device Name: | SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | BIOSTAR MEDICAL PRODUCTS, INC. SUITE 1203 CRYSTAL PLAZA BLD.1 2001 JEFFERSON DAVIS, BOX 2286 Arlington, VA 22202 |
| Contact | Jerry Berkstresser |
| Correspondent | Jerry Berkstresser BIOSTAR MEDICAL PRODUCTS, INC. SUITE 1203 CRYSTAL PLAZA BLD.1 2001 JEFFERSON DAVIS, BOX 2286 Arlington, VA 22202 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-30 |
| Decision Date | 1989-06-23 |