Helena Laboratories · Class II · Cleared May 6, 1988
| K-number | K880698 |
| Device name | TITAN GEL-PC GLYCO-HEME(TM) SYSTEM |
| Applicant | Helena Laboratories |
| Product code | LCP |
| Device class | Class II |
| Decision date | May 6, 1988 |
| Decision | Substantially Equivalent |
| Regulation | 864.7470 |
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