The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Ifa Kit For The Detection Of C-anca Antibodies.
| Device ID | K962360 |
| 510k Number | K962360 |
| Device Name: | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-19 |
| Decision Date | 1996-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545023614 | K962360 | 000 |
| 00813545023607 | K962360 | 000 |
| 00813545023591 | K962360 | 000 |
| 00813545023584 | K962360 | 000 |
| 00813545023577 | K962360 | 000 |