The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Gel Alkaline Phosphatase Isoenzyme Control No.5104.
| Device ID | K895528 |
| 510k Number | K895528 |
| Device Name: | GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-10-25 |