Biosite Incorporated · Class II · Cleared Oct 6, 1998
| K-number | K982245 |
| Device name | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA |
| Applicant | Biosite Incorporated |
| Product code | MHI |
| Device class | Class II |
| Decision date | Oct 6, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.3220 |
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