The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Ifa Hep2 Kit For The Detection Of Antinuclear Antibodies.
| Device ID | K970198 |
| 510k Number | K970198 |
| Device Name: | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Contact | Gary Lehnus Phd |
| Correspondent | Gary Lehnus Phd SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-02-20 |