The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Willcogen Meningitidis Kit Zl25.
| Device ID | K851691 |
| 510k Number | K851691 |
| Device Name: | WILLCOGEN MENINGITIDIS KIT ZL25 |
| Classification | Antisera, All Groups, N. Meningitidis |
| 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 | GTJ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-06-10 |