The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Reaads Anti-sm Test Kit.
| Device ID | K901230 |
| 510k Number | K901230 |
| Device Name: | REAADS ANTI-SM TEST KIT |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| 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 | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-14 |
| Decision Date | 1990-03-23 |