The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Rf Igm Elisa Test System.
| Device ID | K961277 |
| 510k Number | K961277 |
| Device Name: | RF IGM ELISA TEST SYSTEM |
| Classification | System, Test, Rheumatoid Factor |
| 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 | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-03 |
| Decision Date | 1996-05-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239027757 | K961277 | 000 |