TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY— 510(k) K872131

Name: FDA 510(k) clearance K872131
Creator: U.S. Food and Drug Administration
Published: 1987-08-25

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K872131 for TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1987-08-25. 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: 1987-06-04
Decision date: 1987-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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