The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Adp Reagent.
Device ID | K910800 |
510k Number | K910800 |
Device Name: | ADP REAGENT |
Classification | Reagent, Platelet Aggregation |
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 | GHR |
CFR Regulation Number | 864.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-25 |
Decision Date | 1991-05-20 |