PROSPECT/GIARDIA— 510(k) K874849

Substantially Equivalent

Alexon Biomedical, Inc.

FDA 510(k) clearance K874849 for PROSPECT/GIARDIA, Substantially Equivalent on 1988-01-05. Applicant: Alexon Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Alexon Biomedical, Inc.
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1987-11-25
Decision date: 1988-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Ellyn, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Alexon Biomedical, Inc.

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K936191 — PROSPECT CRYPTOSPORIDIUM RAPID ASSAY1994-11-17
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Data sourced from openFDA. This site is unofficial and independent of the FDA.