The following data is part of a premarket notification filed by Reaads Medical Products, Inc. with the FDA for Reaads Anti-phosphatidylserine Quantitative Test Kit.
| Device ID | K952287 |
| 510k Number | K952287 |
| Device Name: | REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | REAADS MEDICAL PRODUCTS, INC. 12001 TEJON ST. SUITE 120 Westminister, CO 80234 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers REAADS MEDICAL PRODUCTS, INC. 12001 TEJON ST. SUITE 120 Westminister, 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 | 1995-05-16 |
| Decision Date | 1995-12-18 |