Helena Laboratories · Class II · Cleared Oct 10, 1980
| K-number | K802233 |
| Device name | GLYCOSYLATED HEMOGLOBIN-SMC COLUMN |
| Applicant | Helena Laboratories |
| Product code | LCP |
| Device class | Class II |
| Decision date | Oct 10, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 864.7470 |
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