The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ck Kit, Model 3332, 3333.
| Device ID | K022757 |
| 510k Number | K022757 |
| Device Name: | SPIFE CK KIT, MODEL 3332, 3333 |
| Classification | Colorimetric Method, Cpk Or Isoenzymes |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JHY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-20 |
| Decision Date | 2002-10-11 |