The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Staphaurex Zl30.
| Device ID | K851949 |
| 510k Number | K851949 |
| Device Name: | STAPHAUREX ZL30 |
| Classification | Antisera, Fluorescent, All Types, Staphylococcus Spp. |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Max D Moody |
| Correspondent | Max D Moody WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | GTN |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-03 |
| Decision Date | 1985-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080501505 | K851949 | 000 |
| 05056080501499 | K851949 | 000 |