SEFRIA PCP Oral Fluid Enzyme Immunoassay
K-Number: K203489 · 2021-04-20
ApplicantImmunalysis Corporation
Decision Date2021-04-20
Product CodeLCM
DecisionSubstantially Equivalent
Device Summary
SEFRIA PCP Oral Fluid Enzyme Immunoassay is a medical device manufactured by Immunalysis Corporation. It received FDA 510(k) clearance on 2021-04-20 under approval number K203489. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SEFRIA PCP Oral Fluid Enzyme Immunoassay?
SEFRIA PCP Oral Fluid Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2021-04-20. It is manufactured by Immunalysis Corporation. The 510(k) number is K203489.
When was SEFRIA PCP Oral Fluid Enzyme Immunoassay approved by the FDA?
SEFRIA PCP Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2021-04-20, under approval number K203489.
What company makes SEFRIA PCP Oral Fluid Enzyme Immunoassay?
SEFRIA PCP Oral Fluid Enzyme Immunoassay is manufactured by Immunalysis Corporation.
What is the FDA product code for SEFRIA PCP Oral Fluid Enzyme Immunoassay?
The FDA product code for SEFRIA PCP Oral Fluid Enzyme Immunoassay is LCM.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.