The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Reads Anti-cardiolipin Semi-quantitative Test Kit.
| Device ID | K902236 |
| 510k Number | K902236 |
| Device Name: | READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer BIOSEARCH MEDICAL PRODUCTS, INC. 5766 CENTRAL AVE. FLATIRON INDUSTRIAL PARK Boulder, CO 80301 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-17 |
| Decision Date | 1990-08-14 |