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 |