The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Specialty Assayed Control-2.
| Device ID | K100103 |
| 510k Number | K100103 |
| Device Name: | SPECIALTY ASSAYED CONTROL-2 |
| Classification | Control, Plasma, Abnormal |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855360006250 | K100103 | 000 |