The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcogen Bacterial Antigen Kit.
| Device ID | K854852 |
| 510k Number | K854852 |
| Device Name: | WELLCOGEN BACTERIAL ANTIGEN KIT |
| 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 | 1985-12-05 |
| Decision Date | 1986-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056080500997 | K854852 | 000 |