The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Alkaline Hb-15 #3196,-8 #3197,-4 3198.
| Device ID | K931465 |
| 510k Number | K931465 |
| Device Name: | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| 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 | JBD |
| CFR Regulation Number | 864.7440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-24 |
| Decision Date | 1993-07-06 |