The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcogen N. Meningitidis A,c,y W135.
| Device ID | K833063 |
| 510k Number | K833063 |
| Device Name: | WELLCOGEN N. MENINGITIDIS A,C,Y W135 |
| Classification | Antisera, All Groups, N. Meningitidis |
| Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTJ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-09 |
| Decision Date | 1984-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080500973 | K833063 | 000 |