The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cardio Rep Recombinant Ck Abnormal Control.
Device ID | K932442 |
510k Number | K932442 |
Device Name: | CARDIO REP RECOMBINANT CK ABNORMAL CONTROL |
Classification | Enzyme 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 | JJT |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-20 |
Decision Date | 1993-10-28 |