The following data is part of a premarket notification filed by Biostar Medical Products, Inc. with the FDA for Reads Rf Test Kit For Igm Rheumatoid Factor.
| Device ID | K863238 |
| 510k Number | K863238 |
| Device Name: | READS RF TEST KIT FOR IGM RHEUMATOID FACTOR |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-21 |
| Decision Date | 1986-10-08 |