The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Proteinase-3 Igg Elisa Test System.
| Device ID | K964448 |
| 510k Number | K964448 |
| Device Name: | PROTEINASE-3 IGG ELISA TEST SYSTEM |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | MOB |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-06 |
| Decision Date | 1997-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027788 | K964448 | 000 |
| 00840239027771 | K964448 | 000 |
| 04048474027785 | K964448 | 000 |
| 04048474027778 | K964448 | 000 |