TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT— 510(k) K860984

Name: FDA 510(k) clearance K860984
Creator: U.S. Food and Drug Administration
Published: 1986-04-29

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K860984 for TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT, Substantially Equivalent on 1986-04-29. Applicant: Hybritech, Inc.. Device class: 1.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1986-03-17
Decision date: 1986-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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