The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcolex Colour Shigella Test Zc51.
| Device ID | K895461 |
| 510k Number | K895461 |
| Device Name: | WELLCOLEX COLOUR SHIGELLA TEST ZC51 |
| Classification | Antisera, All Types, Shigella Spp. |
| Applicant | WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Contact | J Rosenberg |
| Correspondent | J Rosenberg WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park, NC 27709 |
| Product Code | GNB |
| CFR Regulation Number | 866.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1990-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080500492 | K895461 | 000 |