The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Anti-cardiolipin Igs Elisa Test System.
| Device ID | K981020 |
| 510k Number | K981020 |
| Device Name: | ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM |
| Classification | System, Test, Anticardiolipin Immunological |
| 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 | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-19 |
| Decision Date | 1998-05-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027900 | K981020 | 000 |
| 04048474027907 | K981020 | 000 |