The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Reaads-rf Test Kit-semiquantitative.
| Device ID | K892445 |
| 510k Number | K892445 |
| Device Name: | REAADS-RF TEST KIT-SEMIQUANTITATIVE |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. SUITE 1203 CRYSTAL PLAZA BLDG1 2001 JEFFERSON DAVIS, BOX 2286 Arlington, VA 22202 |
| Contact | Jerry Berkstresser |
| Correspondent | Jerry Berkstresser BIOSEARCH MEDICAL PRODUCTS, INC. SUITE 1203 CRYSTAL PLAZA BLDG1 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 | 1989-04-10 |
| Decision Date | 1989-06-05 |