The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Alkaline Phosphatase Indolyl Blue Reagent.
| Device ID | K870890 |
| 510k Number | K870890 |
| Device Name: | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| 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 | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-06-01 |