The following data is part of a premarket notification filed by Reads Medical Products, Inc. with the FDA for Reads(r) Iga Anti-cardiolipin Test Kit.
| Device ID | K914405 |
| 510k Number | K914405 |
| Device Name: | READS(R) IGA ANTI-CARDIOLIPIN TEST KIT |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | READS MEDICAL PRODUCTS, INC. TEJON ST. SUITE 120 METRO TECH CENTRE Westminster, CO 80234 |
| Contact | Debra Songer |
| Correspondent | Debra Songer READS MEDICAL PRODUCTS, INC. TEJON ST. SUITE 120 METRO TECH CENTRE Westminster, CO 80234 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-02 |
| Decision Date | 1991-12-18 |