The following data is part of a premarket notification filed by Val Tech Diagnostics, Inc. with the FDA for Ana Test Kit.
| Device ID | K864668 |
| 510k Number | K864668 |
| Device Name: | ANA TEST KIT |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh, PA 15215 |
| Contact | Steve L Sinka |
| Correspondent | Steve L Sinka VAL TECH DIAGNOSTICS, INC. 14 WERNER CAMP RD. Pittsburgh, PA 15215 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-02 |
| Decision Date | 1987-03-12 |