MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206— 510(k) K991707

Name: FDA 510(k) clearance K991707
Creator: U.S. Food and Drug Administration
Published: 1999-06-01

Substantially Equivalent

Beckman

FDA 510(k) clearance K991707 for MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206, Substantially Equivalent on 1999-06-01. Applicant: Beckman. Device class: 2.

Clearance details

Applicant: Beckman
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1999-05-19
Decision date: 1999-06-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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