TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY— 510(k) K972666

Name: FDA 510(k) clearance K972666
Creator: U.S. Food and Drug Administration
Published: 1997-09-11

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K972666 for TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1997-09-11. Applicant: Hybritech, Inc.. Device class: 2.

Clearance details

Applicant: Hybritech, Inc.
Product code: Code CIN
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1997-07-16
Decision date: 1997-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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