The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Coagulation Arpr,cat.no.5185.
Device ID | K914949 |
510k Number | K914949 |
Device Name: | COAGULATION ARPR,CAT.NO.5185 |
Classification | Plasma, Coagulation Control |
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 | GGN |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-04 |
Decision Date | 1992-03-04 |