The following data is part of a premarket notification filed by Biosite Incorporated with the FDA for Triage,parasite Panel, Triage Cryptosporidium And Entamoeba Histolytica, Triage Cryptosporidium And Giardia Lamblia.
| Device ID | K982245 |
| 510k Number | K982245 |
| Device Name: | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA |
| Classification | Giardia Spp. |
| Applicant | BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Contact | John F Bruni |
| Correspondent | John F Bruni BIOSITE INCORPORATED 11030 ROSELLE ST. San Diego, CA 92121 |
| Product Code | MHI |
| Subsequent Product Code | GMO |
| Subsequent Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-10-06 |
| Summary: | summary |