The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cascase 480 Snslyzer.
Device ID | K951497 |
510k Number | K951497 |
Device Name: | CASCASE 480 SNSLYZER |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
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 | JPA |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-03 |
Decision Date | 1995-09-01 |