The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ana Screen Elisa Test System.
| Device ID | K940362 |
| 510k Number | K940362 |
| Device Name: | ANA SCREEN ELISA TEST SYSTEM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027733 | K940362 | 000 |
| 04048474027730 | K940362 | 000 |