The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cardio Rep Ck Calibrators 1 & 2 Cat. No. 3322 & 3323.
| Device ID | K932768 |
| 510k Number | K932768 |
| Device Name: | CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1993-10-18 |