The following data is part of a premarket notification filed by Helena Laboratories with the FDA for V8 Sp Normal Control, Abnormal Control.
| Device ID | K131479 |
| 510k Number | K131479 |
| Device Name: | V8 SP NORMAL CONTROL, ABNORMAL CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. Beaumont, TX 77704 |
| Contact | Justin Padia |
| Correspondent | Justin Padia HELENA LABORATORIES 1530 LINDBERGH DR. Beaumont, TX 77704 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-22 |
| Decision Date | 2013-10-07 |