TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY— 510(k) K961573

Name: FDA 510(k) clearance K961573
Creator: U.S. Food and Drug Administration
Published: 1996-08-19

Substantially Equivalent

Hybritech, Inc.

FDA 510(k) clearance K961573 for TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY, Substantially Equivalent on 1996-08-19. 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: 1996-04-23
Decision date: 1996-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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