The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Afsc Hemo Control #5331, Aa2 Hemo Control #5328.
| Device ID | K933086 |
| 510k Number | K933086 |
| Device Name: | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 |
| Classification | Control, Hemoglobin, Abnormal |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JCM |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-23 |
| Decision Date | 1994-10-31 |