The following data is part of a premarket notification filed by Reads Medical Products, Inc. with the FDA for Antinuclear Antibody (ana) Screening Test Kit.
| Device ID | K914853 |
| 510k Number | K914853 |
| Device Name: | ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| 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 | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-28 |
| Decision Date | 1992-01-15 |