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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. Type of Use Select one or both as applicable Prescription Use Part 21 CFR 801 Subpart D Over-The-Counter Use 21 CFR 801 Subpart C CONTINUE ON A SEPARATE PAGE IF NEEDED. 510 k Number if known Device Name ImmunoCard STAT HpSA The ImmunoCard STAT HpSA is a rapid in vitro qualitative procedure for the detection of Helicobacter...

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