The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Arachidonic Acid.
Device ID | K912774 |
510k Number | K912774 |
Device Name: | ARACHIDONIC ACID |
Classification | Aggregrometer, Platelet |
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 | JBX |
CFR Regulation Number | 864.6675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-24 |
Decision Date | 1991-08-22 |