The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Anti-cardiolipin Igm Test System.
Device ID | K981021 |
510k Number | K981021 |
Device Name: | ZEUS ANTI-CARDIOLIPIN IGM 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 | 1998-06-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840239027894 | K981021 | 000 |
04048474027891 | K981021 | 000 |