The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Cardio Rep-cat. No. 1400 & Ck Isoforms Kit 3305.
| Device ID | K930359 |
| 510k Number | K930359 |
| Device Name: | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 |
| Classification | Chromatographic Separation, Cpk Isoenzymes |
| 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 | JHT |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-04-12 |