The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcolex Colour Salmonella Test Zl 50.
| Device ID | K890146 |
| 510k Number | K890146 |
| Device Name: | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 |
| Classification | Antisera, All Groups, Salmonella Spp. |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | Moody, Ph.d. |
| Correspondent | Moody, Ph.d. WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | GRM |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-13 |
| Decision Date | 1989-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080500508 | K890146 | 000 |
| 05056080500485 | K890146 | 000 |