The following data is part of a premarket notification filed by Helena Laboratories Uk Ltd with the FDA for The Helena V8 Immunodisplacement Kit.
| Device ID | K111369 |
| 510k Number | K111369 |
| Device Name: | THE HELENA V8 IMMUNODISPLACEMENT KIT |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | HELENA LABORATORIES UK LTD PO BOX 752, 1530 LINDEBERGH DRIVE Beaumont, TX 77704 -0752 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES UK LTD PO BOX 752, 1530 LINDEBERGH DRIVE Beaumont, TX 77704 -0752 |
| Product Code | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2012-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52518250000 | K111369 | 000 |
| M52518200 | K111369 | 000 |
| M52518010000 | K111369 | 000 |
| M52518000010 | K111369 | 000 |
| M52518000000 | K111369 | 000 |