The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel Cpk/ldh Isoenzyme Control.
| Device ID | K821981 |
| 510k Number | K821981 |
| Device Name: | TITAN GEL CPK/LDH ISOENZYME CONTROL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | HELENA LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-06 |
| Decision Date | 1982-07-22 |