The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cardio Rep Ld Control - Cat No. 3325.
| Device ID | K950801 |
| 510k Number | K950801 |
| Device Name: | CARDIO REP LD CONTROL - CAT NO. 3325 |
| 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 | 1995-02-21 |
| Decision Date | 1995-03-30 |